Tissue anchor deployment

ABSTRACT

A tissue anchor delivery device includes a handle, an elongate shaft extending from the handle, a pusher tube disposed at least partially within a lumen of the elongate shaft, a pusher hub coupled to the pusher tube, a needle disposed at least partially within a lumen of the pusher tube, a needle hub coupled to the needle, and an actuator configured to be fixed to the pusher hub and the needle hub. The actuator is further configured to advance the needle hub and the pusher hub a first distance, thereby causing a tip of the needle to protrude from a distal end of the elongate shaft, disengage from the needle hub, and advance the pusher hub a second distance relative to the needle hub, thereby causing a distal end of the pusher tube to advance over the needle and push a coiled suture form off of the needle.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.17/119,961, filed on Dec. 11, 2020, which is a continuation of U.S.application Ser. No. 15/937,582, filed on Mar. 27, 2018, now U.S. Pat.No. 10,864,080, which is a continuation of International Application No.PCT/US2016/055170, filed on Oct. 3, 2016, which claims the benefit ofU.S. Application No. 62/315,879, filed on Mar. 31, 2016; and U.S.Application No. 62/236,225, filed on Oct. 2, 2015, the entiredisclosures all of which are incorporated herein by reference for allpurposes.

BACKGROUND

Some embodiments described herein relate to methods and apparatus forperforming cardiac valve repairs, and more particularly, methods andapparatus for performing minimally invasive mitral or tricuspid valverepairs.

Various disease processes can impair the proper functioning of one ormore of the valves of the heart. These disease processes includedegenerative processes (e.g., Barlow's Disease, fibroelasticdeficiency), inflammatory processes (e.g., Rheumatic Heart Disease), andinfectious processes (e.g., endocarditis). Additionally, damage to theventricle from prior heart attacks (i.e., myocardial infarctionsecondary to coronary artery disease) or other heart diseases (e.g.,cardiomyopathy) can distort the valve's geometry causing it todysfunction. However, the vast majority of patients undergoing valvesurgery, such as mitral valve surgery, suffer from a degenerativedisease that causes a malfunction in a leaflet of the valve, whichresults in prolapse and regurgitation.

Generally, a heart valve may malfunction in two different ways. Onepossible malfunction, valve stenosis, occurs when a valve does not opencompletely and thereby causes an obstruction of blood flow. Typically,stenosis results from buildup of calcified material on the leaflets ofthe valves causing them to thicken and thereby impairing their abilityto fully open and permit adequate forward blood flow.

Another possible malfunction, valve regurgitation, occurs when theleaflets of the valve do not close completely thereby causing blood toleak back into the prior chamber. There are three mechanisms by which avalve becomes regurgitant or incompetent; they include Carpentier's typeI, type II and type III malfunctions. A Carpentier type I malfunctioninvolves the dilation of the annulus such that the area of the valveorifice increases. The otherwise normally functioning leaflets do nothave enough surface area to cover the enlarged orifice and fail to forma tight seal (i.e., do not coapt properly) causing regurgitation.Included in a type I mechanism malfunction are perforations of the valveleaflets, as in endocarditis. A Carpentier's type II malfunctioninvolves prolapse of a segment of one or both leaflets above the planeof the annulus. This is the most common cause of mitral regurgitation,and is often caused by the stretching or rupturing of chordae tendineaenormally connected to the leaflet. A Carpentier's type III malfunctioninvolves restriction of the motion of one or more leaflets such that theleaflets are abnormally constrained below the level of the plane of theannulus. Leaflet restriction can be caused by rheumatic disease (IIIa)or dilation of the ventricle (IIIb).

Mitral valve disease is the most common valvular heart disorder, withnearly 4 million Americans estimated to have moderate to severe mitralvalve regurgitation (“MR”). MR results in a volume overload on the leftventricle which in turn progresses to ventricular dilation, decreasedejection performance, pulmonary hypertension, symptomatic congestiveheart failure, atrial fibrillation, right ventricular dysfunction andeventually death. Successful surgical mitral valve repair restoresmitral valve competence, abolishes the volume overload on the leftventricle, improves symptom status, prevents adverse left ventricularremodeling and dramatically improves life expectancy, often returning itto that of a normal member of the population.

Malfunctioning valves may either be repaired or replaced. Repairtypically involves the preservation and correction of the patient's ownvalve. Replacement typically involves replacing the patient'smalfunctioning valve with a biological or mechanical substitute.Typically, replacement is preferred for stenotic damage sustained by theleaflets because the stenosis is irreversible. The mitral valve andtricuspid valve, on the other hand, are more prone to deformation.Deformation of the leaflets, as described above, prevents the valvesfrom closing properly and allows for regurgitation or back flow from theventricle into the atrium, which results in valvular insufficiency.Deformations in the structure or shape of the mitral valve or tricuspidvalve are often repairable.

In mitral valve regurgitation, repair is preferable to valvereplacement. Mitral valve replacement operations have a 2× higher riskof operative mortality (Risk Standardized Mortality 1.65% vs 2.96%), 2×higher risk of stroke per year (1.15%±0.1% vs 2.2%±0.4%) and a loxhigher risk of infection per year (0.1% vs 1.0%). Patients who receive aquality mitral valve repair operation do not require anticoagulation andrarely require reoperation. This is in stark contrast to mechanicalvalve replacement which mandates lifelong anticoagulation andbioprosthetic valve replacement with the eventual certainty ofprosthetic valve dysfunction and reoperation. Compared to mitral valvereplacement, mitral valve repair results in improved left ventricularfunction and has superior long term survival. Therefore, an improperlyfunctioning mitral valve or tricuspid valve is ideally repaired, ratherthan replaced. However, because of the complex and technical demands ofthe repair procedures, the mitral valve is still replaced inapproximately one third of all mitral valve operations performed in theUnited States.

Studies suggest that Carpentier type II malfunction, often referred toas “Degenerative,” “Primary” or “Organic” MR, accounts for as much as60% of MR. Resectional mitral valve repair techniques, initiallydescribed by Dr. Carpentier, involve cutting out (resecting) a sectionof the prolapsed leaflet tissue, stitching the remaining tissue togetherand implanting an annuloplasty ring around the annulus. More recentlymany surgeons have moved to a “non-resectional” repair technique whereartificial chordae tendineae (“neochords”) made of ePTFE suture, oranother suitable material, are placed in the prolapsed leaflet andsecured to the heart in the left ventricle, normally to the papillarymuscle. Because the native leaflet tissue is maintained innon-resectional repairs, they often result in a larger surface ofcoaptation between the posterior and anterior mitral valve leaflets, butproperly sizing the neochords on a flaccid heart can be verychallenging, especially for the low volume mitral valve surgeon.

Carpentier type I malfunction, sometimes referred to as “Secondary” or“Functional” MR, is associated with heart failure and affects between1.6 and 2.8 million people in the United States alone. Studies haveshown that mortality doubles in patients with untreated mitral valveregurgitation after myocardial infarction. Unfortunately, there is nogold standard surgical treatment paradigm for functional MR and mostfunctional MR patients are not referred for surgical intervention due tothe significant morbidity, risk of complications and prolongeddisability associated with cardiac surgery. Surgeons use a variety ofapproaches ranging from valve replacement to insertion of an undersizedmitral valve annuloplasty ring for patients suffering from functional MRand the long term efficacy is still unclear. Dr. Alfieri hasdemonstrated the benefit of securing the midpoint of both leafletstogether creating a double orifice valve in patients with MR known as an“Edge-to-Edge” repair or an Alfieri procedure. The ability to combine aneochordal repair with an edge-to-edge repair in degenerative MRpatients with a dilated annulus and who do not receive an annuloplastyring because the repair is done in a minimally-invasive, off-pumpprocedure, has particular promise.

Regardless of whether a replacement or repair procedure is beingperformed, conventional approaches for replacing or repairing cardiacvalves are typically invasive open-heart surgical procedures, such assternotomy or thoracotomy, which require opening up of the thoraciccavity so as to gain access to the heart. Once the chest has beenopened, the heart is bypassed and stopped. Cardiopulmonary bypass istypically established by inserting cannulae into the superior andinferior vena cavae (for venous drainage) and the ascending aorta (forarterial perfusion), and connecting the cannulae to a heart-lungmachine, which functions to oxygenate the venous blood and pump it intothe arterial circulation, thereby bypassing the heart. Oncecardiopulmonary bypass has been achieved, cardiac standstill isestablished by clamping the aorta and delivering a “cardioplegia”solution into the aortic root and then into the coronary circulation,which stops the heart from beating. Once cardiac standstill has beenachieved, the surgical procedure may be performed. These procedures,however, adversely affect almost all of the organ systems of the bodyand may lead to complications, such as strokes, myocardial “stunning” ordamage, respiratory failure, kidney failure, bleeding, generalizedinflammation, and death. The risk of these complications is directlyrelated to the amount of time the heart is stopped (“cross-clamp time”)and the amount of time the subject is on the heart-lung machine (“pumptime”).

Thus, there is a significant need to perform mitral valve repairs usingless invasive procedures while the heart is still beating. Accordingly,there is a continuing need for new procedures and devices for performingcardiac valve repairs, such as mitral valve repair, which are lessinvasive, do not require cardiac arrest, and are less labor-intensiveand technically challenging.

SUMMARY

Apparatus and methods for performing a non-invasive procedure to repaira cardiac valve are described herein. In some embodiments, devices todeliver a distal anchor within the atrium of the heart are describedherein. Such a device can include a handle, an actuator operably coupledto the handle, a pusher device, a puncture member coupled to theactuator and at least partially disposed within a lumen defined by thepusher device, and a distal anchor. The distal anchor is disposed at adistal end portion of an artificial chorda and disposed in a deliveryconfiguration. The artificial chorda has a proximal end portion coupledto the actuator. The proximal end portion of the artificial chordaextends through a lumen defined by the puncture member. The actuator canbe actuated to move the puncture member distally a preset distance, andto move the pusher device distally such that at least a portion of thedistal anchor is moved distal to the distal end of the puncture memberand the distal anchor is moved from its delivery configuration to adeployed configuration.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments are depicted in the accompanying drawings forillustrative purposes, and should in no way be interpreted as limitingthe scope of the inventions. In addition, various features of differentdisclosed embodiments can be combined to form additional embodiments,which are part of this disclosure. Throughout the drawings, referencenumbers may be reused to indicate correspondence between referenceelements.

FIG. 1 is a cut-away anterior view of a heart, showing the internalchambers, valves and adjacent structures.

FIG. 2A is a top perspective view of a healthy mitral valve with themitral leaflets closed.

FIG. 2B is a top perspective view of a dysfunctional mitral valve with avisible gap between the mitral leaflets.

FIG. 2C is a cross-sectional view of a heart illustrating a mitral valveprolapsed into the left atrium.

FIG. 2D is an enlarged view of the prolapsed mitral valve of FIG. 2C.

FIG. 3 is a cross-sectional view of a heart showing the left atrium,right atrium, left ventricle, right ventricle and the apex region.

FIG. 4 is a schematic illustration of a delivery device, according to anembodiment, shown inserted into a portion of a heart.

FIG. 5 is a schematic illustration of two anchor-tether apparatus shownimplanted within a heart, according to an embodiment.

FIG. 6 is a schematic illustration of a distal anchor delivery device,according to an embodiment, shown in a first configuration prior todeployment of a distal anchor through a mitral leaflet of a heart andshowing the lumen of the outer tube and the lumen of the pusher device.

FIG. 7 is a schematic illustration of the distal anchor delivery deviceof FIG. 6 , shown in a first configuration during deployment of a distalanchor through a mitral leaflet of a heart.

FIG. 8 is a schematic illustration of the distal anchor delivery deviceof FIG. 6 , shown in a second configuration during deployment of adistal anchor.

FIG. 9 is a schematic illustration of the distal anchor delivery deviceof FIG. 6 , shown in a third configuration showing formation of thedistal anchor during deployment.

FIG. 10 is a schematic illustration of the distal anchor delivery deviceof FIG. 6 , shown in a fourth configuration showing the delivery devicebeing retracted after deployment of the distal anchor.

FIG. 11 is a perspective view of the distal anchor of FIG. 6 shown in anelongated coiled configuration and disposed about the needle of thedelivery device.

FIG. 12 is a side view of the distal anchor of FIG. 6 , shown in acoiled knot configuration.

FIG. 13A is a side view of a single coil/loop variation of the distalanchor of FIG. 6 shown in an elongated coiled configuration; FIG. 13B isa side view of the single coil/loop variation of the distal anchor ofFIG. 13A in a partially coiled knot configuration; and FIG. 13C is aside view of the single coil/loop variation of the distal anchor of FIG.13A in a coiled knot configuration.

FIG. 14A is a schematic illustration of a side view of a distal anchordelivery device according to another embodiment, shown in a firstconfiguration prior to deployment of a distal anchor through a mitralleaflet of a heart.

FIG. 14B is a schematic illustration of a side view of the distal anchordelivery device of FIG. 14A, shown in a second configuration duringdeployment of a distal anchor through a mitral leaflet of a heart.

FIG. 14C is a schematic illustration of a side view of the distal anchordelivery device of FIG. 14A, shown in a third configuration duringdeployment of a distal anchor.

FIG. 14D is a schematic illustration of a side view of the distal anchordelivery device of FIG. 14A, shown in a fourth configuration duringdeployment of the distal anchor.

FIG. 14E is a schematic illustration of a side view of the distal anchordelivery device of FIG. 14A, shown in a fifth configuration as thedelivery device is being retracted after deployment of the distalanchor.

FIG. 15A is a cross-sectional side view of a distal anchor deliverydevice, according to another embodiment.

FIG. 15B is an enlarged cross-sectional side view of a portion of thedistal anchor delivery device of FIG. 15A.

FIG. 15C is a perspective view of a distal end portion of the deliverydevice of FIG. 15A

FIG. 15D is a perspective view of a proximal end portion of the deliverydevice of FIG. 15A showing a suture catch of the delivery device in anopen position.

FIG. 16 is a perspective view shown partially in cross-section of thedistal anchor delivery device of FIG. 15A, shown in a firstconfiguration prior to deployment of a distal anchor through a mitralleaflet of a heart.

FIG. 17A is a perspective view shown partially in cross-section of thedistal anchor delivery device of FIG. 15A, shown in a secondconfiguration during deployment of a distal anchor.

FIG. 17B is a side view of a distal end portion of the delivery deviceof FIG. 15A, shown with the distal anchor in a first configuration.

FIG. 18A is a perspective view shown partially in cross-section of thedelivery device of FIG. 15A, shown during deployment of a distal anchor.

FIG. 18B is a side view of a distal end portion of the delivery deviceof FIG. 15A, shown with the distal anchor in a first configuration.

FIG. 19A is a perspective view shown partially in cross-section of thedelivery device of FIG. 15A, shown in a third configuration.

FIG. 19B is a side view of a distal end portion of the delivery deviceof FIG. 15A, showing formation of the distal anchor into a secondconfiguration during deployment.

FIG. 20A is a perspective view shown partially in cross-section of theanchor delivery device of FIG. 15A, shown in a fourth configurationshowing the delivery device being retracted after deployment of thedistal anchor.

FIG. 20B is a side view of a distal end portion of the delivery deviceof FIG. 15A, showing the delivery device being retracted afterdeployment of the distal anchor.

FIG. 21 is a cross-sectional side view the delivery device of FIG. 15A,showing the pusher hub when released from the plunger during deployment.

FIGS. 22A-22C are a side view, a top view in cross-section, and a sideview in cross-section, respectively, of a fluid transfer system of thedistal anchor delivery device of FIG. 15A.

FIGS. 23-27 illustrate delivery and deployment of a distal anchor usingthe delivery device of FIG. 15A.

FIG. 28A is a schematic illustration of a side view of a distal anchordelivery device according to another embodiment, shown in a firstconfiguration prior to deployment of a distal anchor through a mitralleaflet of a heart.

FIG. 28B is a schematic illustration of a side view of the distal anchordelivery device of FIG. 28A, shown in a second configuration duringdeployment of the distal anchor.

FIG. 28C is a schematic illustration of a side view of the distal anchordelivery device of FIG. 28A, shown in a third configuration duringdeployment of the distal anchor.

FIG. 28D is a schematic illustration of a side view of the distal anchordelivery device of FIG. 28A, shown in a fourth configuration duringdeployment of the distal anchor.

FIG. 28E is a schematic illustration of a side view of the distal anchordelivery device of FIG. 28A, shown in a fifth configuration as thedelivery device is being retracted after deployment of the distalanchor.

FIG. 29A is a schematic illustration of a side view of a distal anchordelivery device according to another embodiment, shown in a firstconfiguration prior to deployment of a distal anchor through a mitralleaflet of a heart.

FIG. 29B is a schematic illustration of a side view of the distal anchordelivery device of FIG. 29A, shown in a second configuration duringdeployment of the distal anchor.

FIG. 29C is a schematic illustration of a side view of the distal anchordelivery device of FIG. 29A, shown in a third configuration duringdeployment of the distal anchor.

FIG. 29D is a schematic illustration of a side view of the distal anchordelivery device of FIG. 29A, shown in a fourth configuration duringdeployment of the distal anchor.

FIG. 29E is a schematic illustration of a side view of the distal anchordelivery device of FIG. 29A, shown in a fifth configuration as thedelivery device is being retracted after deployment of the distalanchor.

FIG. 30A is a schematic illustration of a side view of a distal anchordelivery device according to another embodiment, shown in a firstconfiguration prior to deployment of a distal anchor through a mitralleaflet of a heart.

FIG. 30B is a schematic illustration of a side view of the distal anchordelivery device of FIG. 30A, shown in a second configuration duringdeployment of the distal anchor.

FIG. 30C is a schematic illustration of a side view of the distal anchordelivery device of FIG. 30A, shown in a third configuration duringdeployment of the distal anchor.

FIG. 30D is a schematic illustration of a side view of the distal anchordelivery device of FIG. 30A, shown in a fourth configuration duringdeployment of the distal anchor.

FIG. 30E is a schematic illustration of a side view of the distal anchordelivery device of FIG. 30A, shown in a fifth configuration as thedelivery device is being retracted after deployment of the distalanchor.

FIG. 31 is a schematic illustration of a distal anchor shown in anelongated configuration, according to an embodiment.

FIGS. 32A-32E illustrate in sequence the formation of the distal anchorof FIG. 31 about an exterior of a distal end portion of a deliverydevice, shown in an elongated configuration.

FIGS. 33A-33D illustrate an example procedure for preparing a deliverydevice to deliver a distal anchor, according to an embodiment.

FIGS. 34A-34H illustrate an example method of forming a distal anchorabout an exterior of a needle.

FIG. 35 is a side view of a distal anchor according to anotherembodiment, shown in a first delivery configuration.

FIG. 36 is a side view of the distal anchor of FIG. 35 shown in a seconddeployed configuration.

FIG. 37 is a perspective view of a distal anchor according to anotherembodiment, shown in a delivery configuration.

FIG. 38A is a side view of a distal anchor according to anotherembodiment shown in a first delivery configuration.

FIG. 38B is a side view of the distal anchor of FIG. 38A shown in asecond delivery configuration.

FIGS. 38C and 38D illustrate a side view and a perspective view,respectively, of the distal anchor of FIG. 38A shown in a deployedconfiguration.

FIG. 39A is a side view of a distal anchor according to anotherembodiment shown in a delivery configuration; FIG. 39B is a side view ofthe distal anchor of FIG. 39A shown in a partially deployedconfiguration; and FIG. 39C is a side view of the distal anchor of FIG.39A in a deployed configuration.

FIG. 40A is a side view of a distal anchor according to anotherembodiment shown in a delivery configuration; FIG. 40B is a side view ofthe distal anchor of FIG. 40A shown in a partially deployedconfiguration; and FIG. 40C is a side view of the distal anchor of FIG.40A in a deployed configuration.

FIG. 41A is a side view of a distal anchor according to anotherembodiment, shown in a delivery configuration and disposed within alumen of a delivery device.

FIG. 41B is illustrates the distal anchor of FIG. 41A in the deliveryconfiguration.

FIG. 41C illustrates the distal anchor of FIG. 41A in a partiallydeployed configuration.

FIG. 41D illustrates the distal anchor of FIG. 41A in a deployedconfiguration.

FIGS. 42A and 42B illustrate the distal anchor of FIG. 41A, shown in thedeployed configuration.

FIGS. 43A-43C illustrate a distal anchor according to anotherembodiment, shown in a deployed configuration.

FIG. 44A illustrates a distal anchor according to another embodiment,shown in a delivery configuration.

FIG. 44B illustrates the distal anchor of FIG. 44A, shown with referenceto a valve leaflet and in the delivery configuration.

FIG. 44C illustrates in cross-section the distal anchor of FIG. 44A,shown in the delivery configuration.

FIG. 44D illustrates the distal anchor of FIG. 44A, shown with referenceto the valve leaflet and in a deployed configuration.

FIG. 44E illustrates in cross-section the distal anchor of FIG. 44A,shown with reference to the valve leaflet and in the deployedconfiguration.

FIGS. 45A and 45B are side views of a distal anchor according to anotherembodiment, shown in a delivery configuration and a deployedconfiguration, respectively.

FIG. 45C is a perspective view of the distal anchor of FIGS. 45A and45B, shown in the deployed configuration.

FIG. 46A illustrates a distal anchor according to another embodiment,shown in a in a delivery configuration.

FIG. 46B is a schematic of the distal anchor of FIG. 46A, shown in adeployed configuration.

DETAILED DESCRIPTION

The headings provided herein, if any, are for convenience only and donot necessarily affect the scope or meaning of the claimed invention.

Although certain preferred embodiments and examples are disclosed below,inventive subject matter extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses and tomodifications and equivalents thereof. Thus, the scope of the claimsthat may arise herefrom is not limited by any of the particularembodiments described below. For example, in any method or processdisclosed herein, the acts or operations of the method or process may beperformed in any suitable sequence and are not necessarily limited toany particular disclosed sequence. Various operations may be describedas multiple discrete operations in turn, in a manner that may be helpfulin understanding certain embodiments; however, the order of descriptionshould not be construed to imply that these operations are orderdependent. Additionally, the structures, systems, and/or devicesdescribed herein may be embodied as integrated components or as separatecomponents. For purposes of comparing various embodiments, certainaspects and advantages of these embodiments are described. Notnecessarily all such aspects or advantages are achieved by anyparticular embodiment. Thus, for example, various embodiments may becarried out in a manner that achieves or optimizes one advantage orgroup of advantages as taught herein without necessarily achieving otheraspects or advantages as may also be taught or suggested herein.

Apparatus and methods for performing a non-invasive procedure to repaira cardiac valve, such as a mitral valve or tricuspid valve, aredescribed herein. In some embodiments, a method for repairing a mitralvalve includes inserting a delivery device through an apex region of aheart and extending a distal end of the delivery device to the proximalside of a leaflet of the mitral valve. A piercing portion of thedelivery device can be used to form an opening in the leaflet, throughwhich the distal end of the delivery device can be inserted. Thedelivery device can be used to form or deliver a distal anchor to thedistal side of the leaflet. The location of the opening in the leafletand the placement of the distal anchor can be anywhere in the leafletfrom the free edge up to the base of the mitral valve leaflet and evenin the mitral-annular curtain or annulus of the valve. The deliverydevice can then be withdrawn and a tether coupled to the distal anchorcan be secured to an outer surface of the heart at the apex region with,for example, a proximal anchor. The combined distal anchor, tether andproximal anchor is also referred to herein as an anchor-tetherapparatus. Before the proximal anchor of the anchor-tether apparatus isfixed to the heart, the length of the tether portion can be adjusted sothat the distal movement during systole of the prolapsed segment of theprolapsed leaflet to which the tether portion is coupled by the distalanchor is limited by the tether apparatus during systole. Properlyadjusting the length of the anchor-tether apparatus while the heart isbeating allows the operator to precisely titrate the position of theprolapsed segment of the prolapsed leaflet in real time to prevent theleaflet from extending above the plane of the annulus (prolapsing), butso that the prolapsed segment of the prolapsed leaflet can move distallyduring systole a sufficient distance to coapt properly with the otherleaflet(s). This adjustment can involve shortening or lengthening thetether portion between the distal and proximal anchors of theanchor-tether apparatus. The same procedure can be repeated on the sameleaflet to deliver one or more additional anchor-tether apparatuses tothe leaflet, and or can be performed on the other leaflet of the mitralvalve to deliver one more anchor-tether apparatuses to the other leaflet(or to both of the other leaflets, in the case of a tricuspid valve). Inthe case of multiple anchor-tether apparatuses, the tether adjustmentprocedure can be done one at a time or all at once with the goal ofmaximizing the surface of coaptation between the leaflets, andeliminating MR.

In some embodiments, a delivery device is provided to perform the aboverepair procedure. Such a delivery device can include, for example adistal end portion that includes a piercing portion and a supportportion, an elongate member coupled to the distal end portion, and anactuating handle coupled to a proximal end portion of the elongatemember. The piercing portion of the distal end portion of the deliverydevice can be used to form the opening in the leaflet of the mitralvalve. The support portion of the distal end portion can be used todeliver or form the distal anchor. The handle can include a tethercontrol device that can be used to hold the tether extending from thedistal anchor and secure the tether to the apex region with the proximalanchor.

In some embodiments, an apparatus includes a handle, an actuatoroperably coupled to the handle, a pusher device defining a lumen, apuncture member coupled to the actuator and at least partially disposedwithin the lumen defined by the pusher device, and a distal anchor. Thedistal anchor is disposed at a distal end portion of an artificialchorda and disposed in a delivery configuration. The artificial chordahas a proximal end portion coupled to the actuator. The proximal endportion of the artificial chorda extends through a lumen defined by thepuncture member. The actuator can be actuated to move the puncturemember distally a preset distance and to move the pusher device distallyto move the distal anchor distal to the distal end of the puncturemember and to move the distal anchor from the delivery configuration toa deployed configuration.

In some embodiments, a method includes inserting a distal end portion ofa delivery device through an apex region of a heart, through a ventricleof the heart and to a proximal side of a valve leaflet. The deliverydevice has a distal anchor disposed in a delivery configuration at adistal end portion of the delivery device. A distal end of the deliverydevice is positioned in contact with the proximal side of the leaflet ofthe valve. The delivery device is actuated to move the puncture memberdistally through the leaflet a preset distance outside the distal end ofthe delivery device and on a distal side of the leaflet. The puncturemember forms, creates or otherwise defines an opening in the leaflet asthe puncture member is moved through the leaflet. The distal anchor isdisposed at a distal end portion of an artificial chorda. The artificialchorda extends through a lumen of the puncture member and has a proximalend portion coupled to the delivery device. The actuating the deliverydevice includes moving the distal anchor distally relative to thepuncture member to move the distal anchor to a deployed configuration.

In some embodiments, an apparatus includes a handle, an actuatoroperably coupled to the handle, a pusher device defining a lumen, apuncture member coupled to the actuator and at least partially disposedwithin a lumen defined by the pusher device, and a distal anchor. Thedistal anchor is disposed at a distal end portion of an artificialchorda and disposed in a delivery configuration. The artificial chordahas a proximal end portion coupled to the handle. The proximal endportion of the artificial chorda extends through a lumen defined by thepuncture member. The actuator can be actuated at a first time period tomove the puncture member distally a preset distance and to move thepusher device distally such that at least a portion of the distal anchoris moved distally relative to the puncture member and disposed distal tothe distal end of the puncture member. The actuator can be actuated at asecond time period after the first time period to move the distal anchorfrom its delivery configuration to a deployed configuration.

In some embodiments, a method includes inserting a distal end portion ofa delivery device through an apex region of a heart, through a ventricleof the heart and to a proximal side of a valve leaflet. The deliverydevice has a distal anchor disposed in a delivery configuration at adistal end portion of the delivery device. A distal end of the deliverydevice is positioned in contact with the proximal side of the leaflet ofthe valve. The delivery device is actuated during a first time period tomove the puncture member distally through the leaflet a preset distanceoutside the distal end of the delivery device and on a distal side ofthe leaflet. The puncture member forms, creates, or otherwise defines anopening in the leaflet as the puncture member is moved through theleaflet. The distal anchor is disposed at a distal end portion of anartificial chorda that extends through a lumen of the puncture memberand has a proximal end portion coupled to the actuator. Actuating thedelivery device during the first time period moves the distal anchordistally relative to the puncture member, through the opening in theleaflet such that at least a portion of the distal anchor is disposeddistal to the distal end of the puncture member. The delivery device isactuated during a second time period after the first time period to movethe proximal end portion of the artificial chorda proximally causing thedistal anchor to move to a deployed configuration.

As illustrated in FIG. 1 , the human heart 10 has four chambers, whichinclude two upper chambers denoted as atria 12, 16 and two lowerchambers denoted as ventricles 14, 18. A septum 20 (see, e.g., FIG. 3 )divides the heart 10 and separates the left atrium 12 and left ventricle14 from the right atrium 16 and right ventricle 18. The heart furthercontains four valves 22, 23, 26, and 27. The valves function to maintainthe pressure and unidirectional flow of blood through the body and toprevent blood from leaking back into a chamber from which it has beenpumped.

Two valves separate the atria 12, 16 from the ventricles 14, 18, denotedas atrioventricular valves. The mitral valve 22, also known as the leftatrioventricular valve, controls the passage of oxygenated blood fromthe left atrium 12 to the left ventricle 14. A second valve, the aorticvalve 23, separates the left ventricle 14 from the aortic artery (aorta)29, which delivers oxygenated blood via the circulation to the entirebody. The aortic valve 23 and mitral valve 22 are part of the “left”heart, which controls the flow of oxygen-rich blood from the lungs tothe body. The right atrioventricular valve, the tricuspid valve 24,controls passage of deoxygenated blood into the right ventricle 18. Afourth valve, the pulmonary valve 27, separates the right ventricle 18from the pulmonary artery 25. The right ventricle 18 pumps deoxygenatedblood through the pulmonary artery 25 to the lungs wherein the blood isoxygenated and then delivered to the left atrium 12 via the pulmonaryvein. Accordingly, the tricuspid valve 24 and pulmonic valve 27 are partof the “right” heart, which control the flow of oxygen-depleted bloodfrom the body to the lungs.

Both the left and right ventricles 14, 18 constitute “pumping” chambers.The aortic valve 23 and pulmonic valve 27 lie between a pumping chamber(ventricle) and a major artery and control the flow of blood out of theventricles and into the circulation. The aortic valve 23 and pulmonicvalve 27 have three cusps, or leaflets, that open and close and therebyfunction to prevent blood from leaking back into the ventricles afterbeing ejected into the lungs or aorta 29 for circulation.

Both the left and right atria 12, 16 are “receiving” chambers. Themitral valve 22 and tricuspid valve 24, therefore, lie between areceiving chamber (atrium) and a ventricle so as to control the flow ofblood from the atria to the ventricles and prevent blood from leakingback into the atrium during ejection from the ventricle. Both the mitralvalve 22 and tricuspid valve 24 include two or more cusps, or leaflets(not shown in FIG. 1 ), that are encircled by a variably dense fibrousring of tissues known as the annulus (not shown in FIG. 1 ). The valvesare anchored to the walls of the ventricles by chordae tendineae(chordae; singular “chorda”) 17. The chordae tendineae 17 are cord-liketendons that connect the papillary muscles 19 to the leaflets (not shownin FIG. 1 ) of the mitral valve 22 and tricuspid valve 24 of the heart10. The papillary muscles 19 are located at the base of the chordae 17and are within the walls of the ventricles. The papillary muscles 19 donot open or close the valves of the heart, which close passively inresponse to pressure gradients; rather, the papillary muscles 19 bracethe valves against the high pressure needed to circulate the bloodthroughout the body. Together, the papillary muscles 19 and the chordaetendineae 17 are known as the subvalvular apparatus. The function of thesubvalvular apparatus is to keep the valves from prolapsing into theatria when they close.

The mitral valve 22 is illustrated in FIG. 2A. The mitral valve 22includes two leaflets, the anterior leaflet 52 and the posterior leaflet54, and a diaphanous incomplete ring around the valve, called theannulus 53. The mitral valve 22 has two papillary muscles 19, theanteromedial and the posterolateral papillary muscles (see, e.g., FIG. 1), which attach the leaflets 52, 54 to the walls of the left ventricle14 via the chordae tendineae 17 (see, e.g., FIG. 1 ).

FIG. 2B illustrates a prolapsed mitral valve 22. As can be seen withreference to FIG. 2B-2D, prolapse occurs when a prolapsed segment of aleaflet 52, 54 of the mitral valve 22 is displaced above the plane ofthe mitral annulus into the left atrium 12 (see FIGS. 2C and 2D)preventing the leaflets from properly sealing together to form thenatural plane or line of coaptation between the valve leaflets duringsystole. Because one or more of the leaflets 52, 54 malfunction, themitral valve 22 does not close properly, and, therefore, the leaflets52, 54 fail to coapt. This failure to coapt causes a gap 55 between theleaflets 52, 54 that allows blood to flow back into the left atrium,during systole, while it is being ejected by the left ventricle. As setforth above, there are several different ways a leaflet may malfunction,which can thereby lead to regurgitation.

Mitral valve regurgitation increases the workload on the heart and maylead to very serious conditions if left un-treated, such as decreasedventricular function, pulmonary hypertension, congestive heart failure,permanent heart damage, cardiac arrest, and ultimately death. Since theleft heart is primarily responsible for circulating the flow of bloodthroughout the body, malfunction of the mitral valve 22 is particularlyproblematic and often life threatening.

As described in detail in PCT International Application No.PCT/US2012/043761 (published as WO 2013/003228 A1) (referred to hereinas “the '761 PCT Application”), the entire disclosure of which isincorporated herein by reference, methods and devices are provided forperforming non-invasive procedures to repair a cardiac valve, such as amitral valve. Such procedures include procedures to repair regurgitationthat occurs when the leaflets of the mitral valve do not coapt at peakcontraction pressures, resulting in an undesired back flow of blood fromthe ventricle into the atrium. As described in the '761 PCT Application,after the malfunctioning cardiac valve has been assessed and the sourceof the malfunction verified, a corrective procedure can be performed.Various procedures can be performed in accordance with the methodsdescribed therein to effectuate a cardiac valve repair, which willdepend on the specific abnormality and the tissues involved.

In one example method, the heart may be accessed through one or moreopenings made by a small incision(s) in a portion of the body proximalto the thoracic cavity, for example, between one or more of the ribs ofthe rib cage of a patient, proximate to the xyphoid appendage, or viathe abdomen and diaphragm. Access to the thoracic cavity may be soughtso as to allow the insertion and use of one or more thorascopicinstruments, while access to the abdomen may be sought so as to allowthe insertion and use of one or more laparoscopic instruments. Insertionof one or more visualizing instruments may then be followed bytransdiaphragmatic access to the heart. Additionally, access to theheart may be gained by direct puncture (i.e., via an appropriately sizedneedle, for instance an 18-gauge needle) of the heart from the xyphoidregion. Accordingly, the one or more incisions should be made in such amanner as to provide an appropriate surgical field and access site tothe heart. Access may also be achieved using percutaneous methods. Seefor instance, Full-Spectrum Cardiac Surgery Through a Minimal IncisionMini-Sternotomy (Lower Half) Technique Doty et al. Annals of ThoracicSurgery 1998; 65(2): 573-7 and Transxiphoid Approach Without MedianSternotomy for the Repair of Atrial Septal Defects, Barbero-Marcial etal. Annals of Thoracic Surgery 1998; 65(3): 771-4, which areincorporated in their entirety herein by reference.

After prepping and placing the subject under anesthesia, atransesophageal echocardiogram (TEE) (2D or 3D), a transthoracicechocardiogram (TIE), intracardiac echo (ICE), or cardio-optic directvisualization (e.g., via infrared vision from the tip of a 7.5 Fcatheter) may be performed to assess the heart and its valves.

After a minimally invasive approach is determined to be advisable, oneor more incisions are made proximate to the thoracic cavity so as toprovide a surgical field of access. The total number and length of theincisions to be made depend on the number and types of the instrumentsto be used as well as the procedure(s) to be performed. The incision(s)should be made in such a manner so as to be minimally invasive. Asreferred to herein, the term “minimally invasive” means in a manner bywhich an interior organ or tissue may be accessed with as little aspossible damage being done to the anatomical structure through whichentry is sought. Typically, a minimally invasive procedure is one thatinvolves accessing a body cavity by a small incision of, for example,approximately 5 cm or less made in the skin of the body. The incisionmay be vertical, horizontal, or slightly curved. If the incision isplaced along one or more ribs, it should follow the outline of the rib.The opening should extend deep enough to allow access to the thoraciccavity between the ribs or under the sternum and is preferably set closeto the rib cage and/or diaphragm, dependent on the entry point chosen.

One or more other incisions may be made proximate to the thoracic cavityto accommodate insertion of a surgical scope so as to allow ready accessto and visualization of the heart. The surgical scope may be any type ofendoscope, but is typically a thorascope or laparoscope, dependent uponthe type of access and scope to be used. At this point, the practitionercan confirm that access of one or more cardiac valves through the apexregion of the heart is appropriate for the particular procedure to beperformed.

Once a suitable entry point has been established, the surgeon can useone or more sutures to make a series of stiches in one or moreconcentric circles in the myocardium at the desired location to create a“pursestring” closure. The Seldinger technique can be used to access theleft ventricle in the area surrounded by the pursestring suture bypuncturing the myocardium with a small sharp hollow needle (a “trocar”)with a guidewire in the lumen of the trocar. Once the ventricle has beenaccessed, the guidewire can be advanced, and the trocar removed. Avalved-introducer with dilator extending through the lumen of thevalved-introducer can be advanced over the guidewire to gain access tothe left ventricle. The guidewire and dilator can be removed and thevalved-introducer will maintain hemostasis, with or without a suitabledelivery device inserted therein, throughout the procedure.Alternatively, the surgeon can make a small incision in the myocardiumand insert the valved-introducer into the heart via the incision. Oncethe valved-introducer is properly placed the pursestring suture istightened to reduce bleeding around the shaft of the valved-introducer.

A suitable device such as a delivery device described herein, may beadvanced into the body and through the valved-introducer in a manner soas to access the left ventricle. The advancement of the device may beperformed in conjunction with sonography or direct visualization (e.g.,direct transblood visualization). For example, the delivery device maybe advanced in conjunction with TEE guidance or ICE so as to facilitateand direct the movement and proper positioning of the device forcontacting the appropriate apical region of the heart. Typicalprocedures for use of echo guidance are set forth in Suematsu, Y., J.Thorac. Cardiovasc. Surg. 2005; 130:1348-1356, herein incorporated byreference in its entirety.

As shown in FIG. 3 , one or more chambers, i.e., the left atrium 12,left ventricle 14, right atrium 16, or right ventricle 18 in the heart10 may be accessed in accordance with the methods disclosed herein.Access into a chamber 12, 14, 16, 18 in the heart 10 may be made at anysuitable site of entry but is preferably made in the apex region of theheart, for example, slightly above the apex 26 at the level of thepapillary muscles 19 (see also FIG. 2C). Typically, access into the leftventricle 14, for instance, to perform a mitral valve repair, is gainedthrough the process described above performed in the apical region,close to (or slightly skewed toward the left of) the median axis 28 ofthe heart 10. Typically, access into the right ventricle 18, forinstance, to perform a tricuspid valve repair, is gained through theprocess described above performed in the apical region, close to orslightly skewed toward the right of the median axis 28 of the heart 10.Generally, an apex region of the heart is a bottom region of the heartthat is within the left or right ventricular region and is below themitral valve 22 and tricuspid valve 24 and toward the tip or apex 26 ofthe heart 10. More specifically, an “apex region” AR of the heart (seeFIGS. 2C and 3 ) is within a few centimeters to the right or to the leftof the septum 20 of the heart 10 at or near the level of the papillarymuscles 19. Accordingly, the ventricle can be accessed directly via theapex 26, or via an off apex location that is in the apical or apexregion AR, but slightly removed from the apex 26, such as via a lateralventricular wall, a region between the apex 26 and the base of apapillary muscle 19, or even directly at the base of a papillary muscle19 or above. Typically, the incision made to access the appropriateventricle of the heart is no longer than about, for example, 0.5 cm.Alternatively, access can be obtained using the Seldinger techniquedescribed above.

The mitral valve 22 and tricuspid valve 24 can be divided into threeparts—an annulus (see 53 in FIGS. 2A and 2B), leaflets (see 52, 54 inFIGS. 2A and 2B), and a sub-valvular apparatus. The sub-valvularapparatus includes the papillary muscles 19 (see FIG. 1 ) and thechordae tendineae 17 (see FIG. 1 ), which can elongate and or rupture.If the valve is functioning properly, when closed, the free margins oredges of the leaflets come together and form a tight junction, the areof which, in the mitral valve, is known as the line, plane or area ofcoaptation (see, e.g., encircled area labeled AC in FIG. 27 ). Normalmitral and tricuspid valves open when the ventricles relax allowingblood from the atrium to fill the decompressed ventricle. When theventricle contracts, chordae tendineae properly position the valveleaflets such that the increase in pressure within the ventricle causesthe valve to close, thereby preventing blood from leaking into theatrium and assuring that all of the blood leaving the ventricle isejected through the aortic valve (not shown) and pulmonic valve (notshown) into the arteries of the body. Accordingly, proper function ofthe valves depends on a complex interplay between the annulus, leaflets,and subvalvular apparatus. Lesions in any of these components can causethe valve to dysfunction and thereby lead to valve regurgitation. As setforth above, regurgitation occurs when the leaflets do not coaptproperly at peak contraction pressures. As a result, an undesired backflow of blood from the ventricle into the atrium occurs.

Although the procedures described herein are with reference to repairinga cardiac mitral valve or tricuspid valve by the implantation of one ormore artificial chordae, the methods presented are readily adaptable forvarious types of leaflet and annular repair procedures. In general, themethods herein will be described with reference to a mitral valve 22.

Some embodiments described herein refer to a deliver device thatincludes a needle as a puncture member configured to pierce a cardiactissue such as a mitral valve leaflet. It should be understood thatalthough such embodiments are described with reference to a needle, inalternative embodiments, a deliver device can include any puncturemember suitable to pierce a cardiac tissue and form an openingtherethrough. For example, in some embodiments, a puncture member can bea trocar, guidewire, rod, tube, or the like. As a further example, insome embodiments, a puncture member can include an electrosurgicaldevice, i.e., a device with an electrical circuit (or any suitableelectrical energy source) operating at a frequency (e.g., a highfrequency) configured to cut and/or pierce cardiac tissue.

Some embodiments described herein refer to a delivery device thatincludes a plunger as an actuator configured to receive a manual forceand move within a handle of the delivery device to help deliver anddeploy a distal anchor within a heart. For example, in some embodiments,such a delivery device having a manual plunger actuator can be used todeploy a bulky-knot type distal anchor as described herein. It should beunderstood that although such embodiments are described with referenceto a manually actuated plunger, in alternative embodiments, a deliverydevice can include any suitable actuator, such as, for example, anautomatically actuated plunger, and/or a button that when pressed orotherwise activated can actuate an internal mechanism suitable toselectively move components (e.g., a pusher, a puncture member, asuture, etc.) of the delivery device. As a further example, an actuatorof a delivery device can include one or more energy storage membersconfigured to selectively move components of the delivery device.

In some embodiments, a method includes the implantation of one or moreartificial chordae tendineae into one or more leaflets (e.g., 52, 54 inFIGS. 2A and 2B) of a malfunctioning mitral valve 22 and/or tricuspidvalve 24. After an appropriate incision has been made in the apex regionof the heart, for example, in the apex 26, a delivery device can beintroduced into, for example, the left ventricle 14 of the heart andadvanced in such a manner so as to contact one or more cardiac tissues(for instance, a leaflet, an annulus, a cord, a papillary muscle, or thelike) that are in need of repair. Sonic guidance, for instance, TEEguidance or ICE, may be used to assist in the advancement of the deviceinto the ventricle, the proper positioning of the distal tip of thedevice on the proximal side of the leaflet and, if necessary, thegrasping of the cardiac tissue with the device. Direct trans-bloodvisualization may also be used.

FIG. 4 is a schematic illustration of a portion of a heart with adelivery device inserted therein, according to an embodiment. Thedelivery device 130 can include a distal end portion 132 configured tobe inserted into a heart H, an elongate portion 134 coupled to thedistal end portion 132, and a proximal end portion 136. The distal endportion 132 of the delivery device 130 can include a puncture orpiercing member (not shown) and an anchor support portion (not shown).The distal end portion 132 can include other features to enable thedelivery device 130 to perform various functions, such as, for example,grasping, suctioning, irrigating, cutting, suturing, or otherwiseengaging a cardiac tissue.

The proximal end portion 136 can include, for example, a handle that canbe used by the user/operator to manipulate movement of the deliverydevice 130 and/or to actuate the delivery device 130. The proximal endportion 136 can also include control features and/or components that canbe used to actuate various functions of the delivery device 130. Theproximal end portion 136 can also include a holding device or memberthat can be used to hold and control a tether (e.g., suture, cord orwire) extending from a distal anchor (described in more detail below)during deployment of the distal anchor.

Using, for example, ultrasound guidance (real-time transesophagealechocardiography), the delivery device 130 can be inserted through anaccess port at the apex Ap (or near the apex) of the heart H and guidedthrough the left ventricle LV and into contact with a proximal side of amitral valve leaflet L1 (or L2), shown in FIGS. 4 and 5 , at a locationwhere the user/operator has determined that a repair is needed.Typically, this would be a prolapsed segment of the body of the anterioror posterior leaflet, i.e. in a location where the valve has prolapsedas a result of a broken or elongated chorda. The distal end portion 130of the delivery device 130 can be used to puncture or form an opening inthe valve leaflet L1 and/or the valve leaflet L2. For example, as shownin FIG. 4 , the piercing member at a distal tip 138 can be used topuncture or pierce through the leaflet L2. This can be done with orwithout grasping, capturing, or otherwise immobilizing the prolapsedsegment of the leaflet.

The distal tip 138 of the delivery device 130 can be inserted throughthe puncture site or opening and positioned on a distal side of theleaflet L2 and within the left atrium LA. When the distal tip 138 is inthe desired position, the delivery device 130 can be actuated to inserta distal anchor 140 or form a distal anchor 140 (see, FIG. 5 ) on thedistal side of the leaflet L2 within the left atrium LA of the heart H.In some embodiments, the distal anchor 140 can include a suture or asuture/guide wire combination that can form into a knot upon actuationof the delivery device 130. For example, in some embodiments, the distalanchor 140 includes a large or bulky knot made of ePTFE suture or otherappropriate material that is formed by the delivery device 130 and thatattains a significant size in the left atrium LA, above the leaflet L2.The knot can be in the form of one or more multi-turn coils of thesuture or other material used to form the tether (described in moredetail below), which coils can be changed from an elongatedconfiguration to a knot configuration by approximating opposite ends ofthe coil(s) towards each other to form one or more loops. In someembodiments, the distal anchor 140 includes an anchor member that isdeployed into the left atrium LA above the leaflet L2 upon actuation ofthe delivery device 130.

The distal anchor 140, whether formed by the delivery device 130 ordeployed by the delivery device 130 can be coupled to a tether 142extending proximally from the distal anchor 140 and secured to theproximal end portion 136 of the delivery device 130. Alternatively, thedistal anchor 140 and the tether 142 can be all one component (i.e.,ePTFE suture) where the distal anchor 140 is formed by altering theshape of the tether 142 from a first position to a second position. Asdescribed above, the proximal end portion 136 of the delivery device 130can include a holding device (not shown) that can be used to secure andcontrol the tether 142 during delivery and deployment of the distalanchor 140.

As shown in FIG. 5 , after the distal anchor 140 has been deployed orformed, the delivery device 130 can be withdrawn from the heart H. Thelength of the tether 142 between the distal anchor 140 and the openingin the heart can be adjusted, as discussed above, until the desiredlength is established (i.e. prolapse of the leaflet is prevented, butthe leaflet can still move distally sufficient to coapt with the otherleaflet(s)). The proximal end of the tether 142 can then be secured toan outer surface of the heart H at, for example, the apex Ap region,with a proximal anchor 144. The proximal anchor 144 can be, for example,a pledget, one or more knots, or other suitable anchoring device.

The above procedure can be performed multiple times on the same leaflet,and/or can be performed on the other mitral valve leaflet L1 in the samemanner. The result can thus be that two or more anchor-tetherapparatuses 145 are each anchored on a distal side of a leaflet L1, L2with a distal anchor 140 and secured to the apex Ap region of the heartH with a proximal anchor 144 via the tether 142. Thus, eachanchor-tether apparatus 145 can secure the top of the leaflet L1, L2 tothe apex Ap region of the heart H, functioning as an artificial chordaor neochord.

FIGS. 6-10 show a schematic illustration of an embodiment of a distalanchor that can be deployed on a distal side of a mitral valve leaflet,and a delivery device for deploying such a distal anchor within theheart of a patient. In this embodiment, a distal anchor 240 (see, e.g.,FIGS. 9 and 10 ) includes a pre-formed knot that can be formed/deployedusing a delivery device 230. As shown in FIG. 6 , the delivery device230 includes a distal portion 232, a medial portion 234, and a proximalend portion 236. Disposed on the distal end portion 232 is a distal endeffector 233 that is coupled to a distal end portion of an elongateouter tube 231 and can be placed in contact with a proximal side of amitral valve leaflet L during deployment of the distal anchor 240. Thedistal end effector 233 can distribute the force of the elongate outertube 231 over a larger area to prevent/eliminate puncturing of theleaflet with the delivery device 230 during deployment. In someembodiments, the end effector 233 can include a balloon. A proximal endportion of the outer tube 231 is coupled to a handle 235 at the proximalend portion 236. Coupled to or included at least partially within thehandle 235 are an elongate pusher 237 coupled to a pusher hub 239, apuncture member 241 (e.g., a needle) coupled to a puncture member hub243 (e.g., a needle hub), and a suture catch 246. The pusher 237 ismovably disposed within a lumen of the outer tube 231 and the needle 241is movably disposed within a lumen of the pusher 237. The needle 241includes at a distal end a piercing member or portion 247 as shown inFIG. 7 . In some embodiments, the elongate outer tube 231 can provide arelatively stiff structure and can protect the puncture member 241and/or the pusher 237 during delivery and deployment of the distalanchor, and during withdrawal of the delivery device from within thepatient. In other embodiments, the delivery device does not include anelongate outer tube or distal end effector. In such embodiments, in someinstances, a separate device can be used to provide functionalitysimilar to the functionality provided by the elongate outer tube 231 andthe distal end effector 233 described above.

A suture 242 (also referred to herein as “tether”) is coupled to thesuture catch 246 and extends through a lumen of the needle 241 and isformed into a coiled configuration at the distal end portion 232 of thedelivery device 230 as shown in FIG. 6 . The suture catch 246 can beconfigured to releasably hold or secure the suture 242 during deliveryof the distal anchor 240 as describe in more detail below. In someembodiments, the suture catch 246 can hold the suture 242 with afriction fit or with a clamping force and can have a lock that can bereleased after the distal anchor 240 has been deployed/formed. Thedistal coiled portion of the suture 242 will be formed into the distalanchor 240 upon actuation of the delivery device 230 as described inmore detail below. As discussed above for distal anchor 140, the distalanchor 240 (e.g., bulky knot) can be in the form of one or moremulti-turn coils of the suture 242 that can be changed from an elongatedconfiguration during delivery (see, e.g., FIGS. 7, 11, and 13A) to aknot configuration (see, e.g., FIGS. 9, 10, 12 and 13C) by approximatingopposite ends of the coil(s) towards each other, to form one or moreloops. For example, two strands or lengths of the suture 242 extend fromopposite ends of the elongate coiled portion of the suture 242 andextend through the delivery device 230. When the two proximal ends ofthe suture 242 are pulled proximally, the opposite ends of the coiledportions are pulled towards each other to form the loops.

FIGS. 13A-13C illustrate the sequence described above with respect tothe distal anchor 140 and the distal anchor 240 transitioning from anelongated configuration to a knot configuration, however for ease ofillustration, a single coil and loop variation is shown and described.As shown in FIG. 13A, the distal anchor 240′ is in a coiled, elongatedformation (e.g., a preformed knot) configured for delivery to a heart.To form the knot configuration (as shown in FIG. 13C), a proximal end ofthe suture 242′ is pulled proximally to deflect the distal end DE of thecoil laterally with respect to the proximal end PE of the coil and todraw the proximal end PE of the coil and the distal end DE of the coiltowards each other to form a loop L, as illustrated in FIGS. 13B and13C.

To deliver and form the distal anchor 240 within, for example, a leftatrium of the heart to repair a mitral valve, the distal end portion ofthe needle 241 of the delivery device 230 can be inserted through anapex portion of the heart and into the left ventricle until the endeffector 233 contacts a proximal side of the mitral valve leaflet L asshown in FIGS. 6-9 . With the delivery device 230 positioned against themitral leaflet L, and with a proximal end portion of the suture 232(i.e., the two proximal end portions of the suture 242) secured to thesuture catch 246, the needle 241 and needle hub 243, the pusher 237 andpusher hub 239, and the suture catch 246 are all moved distally (in thedirection of arrow A) relative to the handle 235 as shown in FIG. 7 ,until the pusher 237 and pusher hub 239 locks into place relative to thehandle 235. As these components are collectively moved distally, thepiercing portion 247 of the needle 241 punctures the leaflet L formingan opening, and is passed through the leaflet L and is disposed on thedistal side of the leaflet L. In some embodiments, the distal end ofpiercing portion 247 extends outside of the end effector 233 of thedelivery device 230 about 1.0 inch. Simultaneously, the pusher 237pushes or moves the distal anchor 240 (i.e., the distal coiled portionof the suture 232), still in an elongated configuration and surroundinga portion of the needle 241, through the opening in the leaflet L untilit is disposed on the distal side of the leaflet L. As shown in FIG. 7 ,the piercing portion 247 of the needle 241 extends beyond the distalanchor 240.

As shown in FIG. 8 , the needle 241 and needle hub 243 can then bewithdrawn or moved proximally in the direction of arrow B until contactis made between the needle hub 243 and the suture catch 246, leaving thedistal anchor 240 in the left atrium on the distal side of the leafletL. As the needle hub 243 (and needle 241) continue to be movedproximally in the direction of arrow B, the distal anchor 240 will beginto form a knot because the suture 242 (e.g., the two end portions ofsuture 242) is secured to the suture catch 246 such that as the suturecatch 246 is moved proximally it pulls the distal anchor 240approximating opposite ends of the coils towards each other to form oneor more loops as show in FIGS. 9 and 10 . Further, there is a length ofsuture 242 between the suture catch 246 and the proximal end of theneedle 241 which allows the suture 242 to slide off the needle 241before the knot is formed. When the needle 241 is withdrawn, the wrapsof the suture 242 stay in the same place, eliminating the extra lengthof suture 242 between the distal end of the needle 241 and the suturecatch 246. The knot is thus formed on a distal end of the pusher 237 andnot against the mitral valve leaflets. After the distal anchor 240 hasformed a knot (as in FIGS. 9 and 10 ), the proximal end portions of thesuture 242 can be released from the suture catch 246 and the deliverydevice 230 can be withdrawn proximally in the direction of arrow B,leaving the distal anchor 240 disposed on the distal side of the leafletL, and two lengths of the suture 242 extending out of the heart. Inother words, with the suture 242 released from the suture catch 246, thedelivery device 230 can be slid over the suture 242 for removal.

As described above for distal anchor 140 and tether 142, the length ofthe suture 242 between the distal anchor 240 and the opening in theheart can be adjusted, as discussed above, until the desired length isestablished (i.e. prolapse of the leaflet is prevented, but the leafletcan still move distally sufficient to coapt with the other leaflet(s)).The proximal ends of the suture 242 can then be secured to an outersurface of the heart at, for example, the apex region, with a proximalanchor (not shown). The proximal anchor can be, for example, a pledget,one or more knots, or other suitable anchoring device. As previouslydescribed, the above procedure can be performed multiple times on thesame leaflet, and/or can be performed on the other mitral valve leafletin the same manner. The result can thus be that one or moreanchor-tether apparatuses (e.g., anchor-tether apparatus 145) asdescribed above are each anchored on a distal side of a leaflet with adistal anchor and secured to the apex of the heart with a proximalanchor via the suture 242. Alternatively, if one or more anchor-tetherapparatus are attached to both mitral valve leaflets, an anchor-tetherapparatus attached to each leaflet can be secured together in the heartby tying them together with knots or by another suitable attachmentmember (not shown), creating an edge-to-edge repair to decrease theseptal-lateral distance of the mitral valve orifice. The two attachedanchor-tether apparatus can be left loose or tensioned to create a“facilitated” edge-to-edge repair before being secured to an outersurface of the heart with a proximal anchor.

FIGS. 6-10 illustrate one example method and device for deploying abulky knot distal anchor. In another embodiment, a bulky knot distalanchor can be deployed/formed using a delivery device that utilizes ashort throw deployment sequence configured to insert the distal endportion and piercing member of the needle a shorter distance into theleft atrium than as shown and described above for the embodiment ofFIGS. 6-10 . In such an embodiment, the distal end portion of the needleis used to puncture the leaflet tissue and form an opening in theleaflet tissue, but does not extend as far into the left atrium. In someembodiments, the needle can be extended outside of the distal end of thedelivery device (e.g., beyond the end effector) half the distance thanwhat is shown and described for the embodiment of FIGS. 6-10 . Forexample, in some embodiments, the needle can be extended outside thedelivery device a distance of about 0.2-0.3 inches (e.g., 0.25 inches).In other embodiments, the needle can be extended outside the deliverydevice a distance of about 0.15-0.4 inches. Similarly, in someembodiments, a needle can be extended through a proximal side of a heartvalve leaflet a distance, for example, of about 0.2-0.3 inches or adistance of about 0.15-0.4 inches from the proximal side of the heartvalve leaflet. As yet a further example of the short throw deploymentsequence, the needle can be moved a distance sufficient to pierce theproximal side of the leaflet and extend a distance of about 0.05-0.25inches (e.g., 0.1 inch) from and distal to the distal side of theleaflet. The distal coiled portion of the suture is then moved distallyover the needle and into the left atrium using a pusher device. Byshortening the distance in which the needle is extended outside of theend effector and into the left atrium, the potential for damage tosurrounding tissue can be reduced or eliminated. Further, in some cases,such a short throw deployment sequence can help limit or prevent damageto the needle itself. For example, in some cases, if the needle isextended too far distally outside of the outer tube, the needle may bendunwantedly. FIGS. 14A-14E are schematic illustrations of an embodimentof a delivery device for delivering and deploying a distal anchor andconfigured to provide such a short throw deployment sequence.

As shown in FIGS. 14A-14E, a delivery device 330 includes a distal endportion 332, a proximal end portion 336 and a medial portion 334. Thedistal end portion 332 can include an end effector 333 that can beplaced in contact with a leaflet L of a mitral valve as described above.The end effector 333 can be coupled to a distal end portion of an outertube 331 and a proximal end portion of the outer tube 331 is coupled toa handle 335 at the proximal end portion 336. The end effector 333 candistribute the force of the outer tube 331 over a larger area toprevent/eliminate puncturing of the leaflet with the delivery device 330during deployment. In some embodiments, the end effector 333 can includea balloon. An elongate pusher 337 is movably disposed within a lumen ofthe outer tube 331 and is coupled to a pusher hub 339 that is movablydisposed within the handle 335 and releasably coupled to a plunger (notshown). A needle 341 (see FIGS. 14C and 14D) is movably disposed withina lumen of the pusher 337 and is coupled to a needle hub 243 that isalso coupled to the plunger (not shown). The plunger is used to actuateor move the needle 341 and the pusher 337 during deployment of a distalanchor 340 and can be movably disposed at least partially within thehandle 335 as described in more detail below for delivery device 430.For example, the handle 335 defines a lumen in which the plunger can bemoved. During operation, the pusher 337 also moves within the lumen ofthe handle 335 as described in more detail below. The delivery device330 can also include a locking lever (not shown) that can be used toprevent the plunger from moving within the handle 335 during storage andprior to performing a procedure to deploy the distal anchor.

A suture catch 346 (also referred to as “tether catch”) is also coupledto the plunger at a proximal end of the delivery device 330. The suturecatch 346 can be configured to releasably hold or secure a suture 342extending through the delivery device 330 during delivery of the distalanchor 340 as described above and as described in more detail below withreference to delivery device 430. In some embodiments, the suture catch346 can hold the suture 342 with a friction fit or with a clamping forceand can have a suture lock that can be released after the distal anchor340 has been deployed/formed into a bulky knot.

The suture 342 (also referred to herein as “tether”) is formed into anelongated coiled configuration and is disposed within the outer tube 331at the distal end portion 332 of the delivery device 330. As describedabove for suture 242, two strands of the suture 342 extend from thedistal elongated coiled portion of the suture 342, extend through thelumen of the needle 341, through a passageway of the plunger and exitthe plunger and needle 341 at a proximal end portion of the plunger. Thedistal elongated coiled portion of the suture 342 will be formed intothe distal anchor 340 (e.g., bulky knot) upon actuation of the deliverydevice 330 as described in more detail below. As discussed above fordistal anchors 140 and 240, the distal anchor 340 can be in the form ofone or more multi-turn coils of the suture 342 that can be changed fromthe elongated coiled configuration during delivery to a knotconfiguration by approximating opposite ends of the coils towards eachother, to form one or more loops.

To deliver and form the distal anchor 340 within, for example, a leftatrium of the heart to repair a mitral valve, the distal end portion of332 of the delivery device 330 can be inserted through an apex portionof the heart and into the left ventricle until the end effector 333contacts a proximal side of the mitral valve leaflet L as shown in FIG.14A. In this embodiment, with the delivery device 330 positioned againstthe mitral leaflet L, and with a proximal end portion of the suture 342(e.g., two suture strands of suture 342) secured to the suture catch346, the plunger (not shown) is actuated to move the needle hub 343, theneedle 341, the pusher 337 and pusher hub 339, and the coiled portion ofthe suture 332 (e.g., distal anchor 340) distally until the plungercontacts a stop member (not shown) within the handle 335, which limitsthe travel of the plunger in the distal direction. As the plunger isactuated, a distal piercing portion 347 of the needle 341 and in somecases, at least the first wrap of the coiled portion of the suture,punctures the leaflet L and forms an opening in the leaflet L (see e.g.,FIG. 14B). The distance the distal end portion of the needle 341 extendswithin the left atrium on the distal side of the leaflet L is determinedby the amount of travel allowed by the plunger. Thus, in thisembodiment, the delivery device 330 is configured to advance the distalend portion of the needle 341 a shorter distance, for example, betweenabout 0.2-0.3 inches (e.g., 0.25 inches), or less, distally beyond thedistal end of the delivery device 330 (e.g., beyond the end effector333), compared to the embodiment of FIGS. 6-10 in which the needleextends about 1.0 inch. In other embodiments, the needle can be extendedoutside the delivery device a distance of about 0.15-0.4 inches. Whenthe plunger reaches the stop member, the pusher 337 and pusher hub 339are released from the plunger 348 and are advanced further distally to adistal position within the handle 335 (see FIG. 14C) where the pusherhub 339 (and pusher 337) can optionally lock into place. Details of howthe pusher 337 and pusher hub 339 are moved within the lumen of thehandle 335 are described below with respect to delivery device 430.

As the pusher 337 is moved distally, a distal end of the pusher 337moves or pushes the distal coiled portion of the suture 342 (i.e.,distal anchor 340) over the distal end of the needle 341 and furtherwithin the left atrium of the heart on a distal side of the mitralleaflet (see FIG. 14C). In other words, the distal end of the pusher 337and the distal coiled portion of the suture 342 extends beyond thedistal end of the needle 341. For example, in some embodiments, at leasthalf a length of the distal coiled portion of the suture 342 extendsbeyond the distal end of the needle 341. In some embodiments, at leastthree quarters of the length of the distal coiled portion of the suture342 extends beyond the distal end of the needle 341. In otherembodiments, the entire length of the distal coiled portion of thesuture 342 extends beyond the distal end of the needle 341. To allow thedistal coiled portion of the suture 342 (i.e., distal anchor 340) toslide relative to the plunger, when the suture 342 is loaded within thedelivery device 330, there is slack in the suture 342 between the distalcoiled portion of the suture 342 and the suture lock within the suturecatch 346.

After the distal coiled portion of the suture 342 is moved to the distalside of the leaflet L, the plunger is then released such that theplunger moves proximally, which moves or pushes the needle 341 andsuture catch 346 proximally, pulling the suture 342 (e.g., suturestrands extending from the coiled portion of the suture) through thepusher 337 to form the bulky knot configuration (as shown in FIG. 14D)of the distal anchor 340 by approximating opposite ends of the coils ofthe elongated coil portion of the suture 342 towards each other, to formone or more loops. As shown in FIG. 14D, by pulling on the proximal endsof the suture 342, the coils are pulled against the distal end of thepusher 337 to form the knot. After the distal anchor 340 has formed aknot, the proximal end portions of the suture 342 can be released fromthe suture catch 346 and the delivery device 330 can be withdrawnproximally, leaving the distal anchor 340 disposed on the distal side ofthe leaflet L (as shown in FIG. 14E), and two lengths or strands of thesuture 332 extending out of the heart. In other words, with the suture342 released from the suture catch 346, the delivery device 330 can beslid over the suture 342 for removal.

As described above for previous embodiments, the lengths or strands ofthe suture 342 between the distal anchor 340 and the opening in theheart can be adjusted until the desired length is established. Theproximal ends of the suture 342 can then be secured to an outer surfaceof the heart at, for example, the apex region, with a proximal anchor(not shown). The proximal anchor can be, for example, a pledget, one ormore knots, or other suitable anchoring device. As previously described,the above procedure can be performed multiple times on the same leaflet,and/or can be performed on the other mitral valve leaflet in the samemanner. The result can thus be that one or more anchor-tetherapparatuses (e.g., anchor-tether apparatus 145) as described above areeach anchored on a distal side of a leaflet with a distal anchor andsecured to the apex of the heart with a proximal anchor via the tether342. Alternatively, if one or more anchor-tether apparatus are attachedto both mitral valve leaflets an anchor-tether apparatus attached toeach leaflet can be secured together in the heart by tying them togetherwith knots or by another suitable attachment member (not shown),creating an edge-to-edge repair to decrease the septal-lateral distanceof the mitral valve orifice. The two attached anchor-tether apparatuscan be left loose or tensioned to create a “facilitated” edge-to-edgerepair before being secured to an outer surface of the heart with aproximal anchor.

FIGS. 15A-22C and 23-27 illustrate another embodiment of a deliverydevice that can be used to deliver and form a bulky knot distal anchorto be disposed on a distal side of a mitral valve leaflet using a shortthrow deployment sequence. As shown in cross-section in FIGS. 15A and15B, a delivery device 430 includes a distal end portion 432, a proximalend portion 436 and a medial portion 434. The distal end portion 432 caninclude an end effector 433 (best shown in FIG. 15C) that can be placedin contact with a leaflet of a mitral valve as described above. The endeffector 433 can be coupled to a distal end portion of an outer tube 431(also shown in FIG. 15C) and a proximal end portion of the outer tube431 is coupled to a handle 435 at the proximal end portion 436. Anelongate pusher 437 is movably disposed within a lumen of the outer tube431 (see e.g., FIG. 15C) and is coupled to a pusher hub 439 that ismovably disposed within the handle 435 and releasably coupled to aplunger 448. A needle 441 is movably disposed within a lumen of thepusher 437 (see e.g., FIG. 17B) and is coupled to a needle hub 443 thatis also coupled to the plunger 448. The plunger 448 is used to actuateor move the needle 441 and the pusher 437 during deployment of a distalanchor 440 (see e.g., FIGS. 19B and 20B) and is movably disposed atleast partially within the handle 435. For example, the handle 435defines a lumen in which the plunger 448 can be moved. During operation,the pusher 437 also moves within the lumen of the handle 435 asdescribed in more detail below. The delivery device 430 also includes alocking lever 449 that can be used to prevent the plunger 448 frommoving within the handle 435 during storage and prior to performing aprocedure to deploy the distal anchor.

A suture catch 446 (also referred to as “tether catch”) is also coupledto the plunger 448 at a proximal end of the delivery device 430 (bestshown in FIG. 15D). The suture catch 446 can be configured to releasablyhold or secure a suture 442 extending through the delivery device 430during delivery of the distal anchor as described above and as describedin more detail below. In some embodiments, the suture catch 446 can holdthe suture 442 with a friction fit or with a clamping force and can havea lock that can be released after the distal anchor 440 has beendeployed/formed into a bulky knot. The suture catch 446 includes an arm480 and contact members 481 (e.g., silicon o-rings) coupled to the arm480 (see e.g., FIG. 12D). The arm 480 can be moved from a closedposition (as shown in FIGS. 15A, 15B, 16, 17A, 18A and 19A) in which thecontact members 481 engage the suture strands 442 within a slot 483 inthe plunger 448, to an open position (as shown in FIGS. 15D and 20A)thereby allowing the proximal end portions of the suture 442 to bereleased from the suture catch 446. The delivery device 430 can then bewithdrawn proximally, leaving the distal anchor 440 disposed on thedistal side of the leaflet L, and the two lengths of the suture 442extending out of the heart, as described with respect to previousembodiments. When in the closed position, the arm 480 and the contactmembers 481 pinch or otherwise secure the suture 442 to prevent orotherwise limit the suture 442 from moving relative to the device 430.When in the open position (e.g., after delivery of the distal anchor 440and during removal of the device 430 from the heart), the arm 480 andthe contact members 481 allow movement of the suture 442 relative to thedevice 430 such that the device 430 can be separated from the suture442, as described in more detail below.

A distal end portion of the suture 442 (also referred to herein as“tether”) is formed into an elongated coiled configuration and isdisposed within the outer tube 431 at the distal end portion 432 of thedelivery device 430. For example, the coils of the suture 442 can beprovided or shipped disposed around the needle 441 with the proximalmost coil abutting against the suture 442. As described above for thesuture 242 and the suture 342, two strands of the suture 442 extend fromthe distal elongated coiled portion of the suture 442, extend throughthe lumen of the needle 441, through a passageway of the plunger 448 andexit the plunger 448 at a proximal end portion of the plunger 448 (seee.g., FIG. 15D). The distal elongated coiled portion of the suture 442will be formed into the distal anchor 440 (e.g., bulky knot) uponactuation of the delivery device 430 as described in more detail below.As discussed above for the distal anchors 140, 240 and 340, the distalanchor 440 (e.g., bulky knot) can be in the form of one or moremulti-turn coils of the suture 442 that can be changed from theelongated coiled configuration during delivery to a knot configurationby approximating opposite ends of the coils towards each other, to formone or more loops.

As shown in detail in FIGS. 22A-22C, the delivery device 430 alsoincludes a fluid transfer system 460. The fluid transfer system 460 isconfigured to facilitate flushing of a portion of the delivery device430 and/or to facilitate the removal of undesirable fluids during theprocedure. In some instances, for example, the fluid transfer system 460be used to flush air out of the delivery device 430 (e.g., air locatedbetween the pusher 437 and the outer tube 431). As another example, thefluid transfer system 460 can be used to limit or prevent blood fromundesirably flowing from a patient into the delivery device 430 during aprocedure. The fluid transfer system 460 includes a fluid pathway 461and a connection port 462 disposed external to the handle 435. As shownbest in cross-sectional view in FIG. 22C, the fluid pathway 461 is influid communication with the connection port 462 and a volume definedbetween the lumen of the outer tube 431 and an outer surface of thepusher 437. Further, as shown best in FIG. 22C, the fluid transfersystem 460 includes a fluid sealing member 465 (e.g., an o-ring)disposed about the pusher 437 and configured to fluidically isolate thefluid pathway 461 from a volume within the handle 435 proximal to thefluid transfer system 460. The fluid transfer system 460 also includesconnection port sealing member 463 (e.g., a cap, a plug, or the like)configured to be coupled to the connection port 462 to fluidicallyisolate the fluid pathway 461 from a volume external to the fluidtransfer system 460 and/or the delivery device 430. Optionally, theconnection port sealing member 463 can be retained and/or storedproximate to the connection port 462 via a leash member 464 (as shown inFIG. 22A).

To prepare the delivery device 430 for delivering and forming a distalanchor 440 within, for example, a left atrium of the heart to repair amitral valve, the locking lever 449 is released from its locked orengaged position (e.g., its position during storage of the deliverydevice 430) in which the plunger 448 is prevented from moving (e.g.,proximally and distally) within the handle 435 to its unlocked ordisengaged position in which the plunger 448 can be moved within thehandle, as described in further detail below.

To deliver and form the distal anchor 440 within, for example, a leftatrium of the heart to repair a mitral valve, the distal end portion of432 of the delivery device 430 can be inserted through an apex portionof the heart and into the left ventricle until the end effector 433contacts a proximal side of the mitral valve leaflet L as shown inprogression in FIGS. 23 and 24 . With the delivery device 430 positionedagainst the mitral leaflet L (see e.g., FIG. 24 ), and with a proximalend portion of the suture 442 (e.g., two suture strands of the suture442) secured to the suture catch 446, the plunger 448 is actuated tomove the needle hub 443, the needle 441, the pusher 437 and pusher hub439, and the coiled portion of the suture 432 (e.g., the distal anchor440) distally until the plunger 448 contacts a stop member 421 withinthe handle 435 (see e.g., FIG. 18A), which limits the travel of theplunger 448 in the distal direction. As the plunger 448 is actuated, adistal piercing portion 447 of the needle 441 punctures the leaflet Land forms an opening in the leaflet L (see e.g., FIG. 17B). Because theneedle 441 is coupled to the plunger 448 and moves with the plunger 448,the distance the distal end portion of the needle 441 extends within theleft atrium on the distal side of the leaflet L (see, e.g., FIG. 17B) isdetermined by the amount of travel allowed by the plunger 448. Thus, inthis embodiment, the delivery device 430 is configured to advance thedistal end portion of the needle 441 a shorter distance, for example,between about 0.2-0.3 inches (e.g., 0.25 inches), or less, distallybeyond the distal end of the delivery device 430 (e.g., beyond the endeffector), compared to the embodiment of FIGS. 6-10 in which the needleextends about 1.0 inch. In other embodiments, the needle can be extendedoutside the delivery device a distance of about 0.15-0.4 inches. Forexample, in some embodiments, the needle extends until the distal tip ofthe needle 441 and a first wrap or two of the coiled suture 442 extendthrough the leaflet. When the plunger 448 reaches the stop member, thepusher 437 and pusher hub 439 are released from the plunger 448 and areadvanced further distally to a distal position within the handle 435, asshown in progression in FIGS. 17A and 18A. Details of how the pusher 437and pusher hub 439 are moved within the lumen of the handle 435 andreleased from the plunger 448 are described below with respect to FIGS.18A-21 .

As shown in FIGS. 17A and 18A, the pusher hub 439 is configured tocomplimentarily mate with an opening 492 defined by and located at adistal end portion of the plunger 448. In use, prior to deployment, aproximal end portion of the pusher hub 439 is disposed within theopening 492 defined by the plunger 448 (see, e.g., FIGS. 16 and 17A). Inthis position, a pair of tabs 485 of a spring member 486 coupled to thepusher hub 439 are disposed within slots 487 defined by the plunger 448.For example, the spring member 486 can have a biased configuration inwhich the tabs 485 are disposed in an open position, and when the pusherhub 439 is coupled to the plunger 448 the tabs 485 are compressed by theinner walls of the handle 435, which define a first portion FP of apassageway within the handle 435. As the pusher hub 439 is moveddistally, the spring member 486 will slide into a second portion SP ofthe passageway of the handle 435 which has a larger size, allowing thetabs 485 to move to their biased open configuration and disengaging thetabs 485 from the slots 487 of the plunger 448 (see, e.g., theprogression in FIGS. 17A and 18A).

When the plunger 448 is actuated (i.e., moved distally within the handle435), the pusher hub 439 will move distally with the plunger 448 untilthe plunger 448 reaches the stop member 421 (see e.g., FIG. 18A), atwhich point the pusher hub 439 is moved into the second portion SP ofthe passageway of the handle 435 as described above, allowing the tabs485 on the spring member 486 to disengage or release the pusher hub 439from the plunger 448. Upon release from the plunger 448, the pusher 437and the pusher hub 439 are advanced further distally to a distalposition within the handle 435 as shown in FIG. 18A, in response to aforce provided by a biasing member 490 (e.g., a compression spring)disposed within a lumen of the plunger 448. The biasing member 490 iscoupled to and disposed between the pusher hub 439 and the needle hub443, as shown in FIG. 21 . In this manner, with use of the biasingmember 490, a desirable and repeatable force can be applied to thepusher 437 and the pusher hub 439, resulting in a desirable andrepeatable delivery of the distal anchor 440.

Prior to disengagement of the pusher 437 and the pusher hub 439 from theplunger 448 (e.g., prior to use of the delivery device 430 or during useas the distal piercing portion 447 of the needle 441 punctures theleaflet L and forms an opening in the leaflet L), the biasing member 490is in a compressed configuration (not shown) and the pusher 437 and thepusher hub 439 are in their ready state (see e.g., FIGS. 16 and 17A), inwhich a portion of the pusher hub 439 is disposed within the opening 492of the plunger 448 as described above. To releasably retain the biasingmember 490 in the compressed configuration and the pusher 437 and pusherhub 439 in their ready state, the pair of tabs 485 of the spring member486 are disposed within the slots 487 of the plunger 448 and the plunger448 is disposed in the first portion of the passageway within the handle435.

As shown in FIG. 21 , a guide member 455 is disposed within a lumendefined by the biasing member 490 and coupled to the pusher hub 439.During distal advancement of the pusher 437 and the pusher hub 439within the handle 435, and transition of the biasing member 490 betweenits unbiased compressed configuration and is biased uncompressedconfiguration, the guide member 455 can facilitate desirable alignmentwithin the handle 435 (e.g., alignment within the handle 435 of thepusher 437, the pusher hub 439, and the plunger 448). In addition, theguide member 455 can provide structural support to the biasing member490 (e.g., during transition of the biasing member 490 between itsbiased and unbiased configurations).

Although the lumen of the handle 435 is shown in this embodiment asbeing rectangular, in some embodiments, the lumen of the handle can haveany suitable shape (e.g., a circular or semi-circular shape). In suchembodiments, the components that cooperatively function within thehandle 435 (e.g., the pusher 437, the pusher hub 439, the plunger 448),as described above with respect the delivery device 430, can be suitablysized and/or shaped to cooperatively function with any shape and/or sizeselected for a particular handle and lumen defined therein.

In use, as the plunger 448 is actuated to move the pusher 437 and thepusher hub 439 distally within the handle 435, the plunger 448 willreach the stop member 421 at which point in time the spring member 486will slide into the second portion SP of the passageway of the handle435 which has the larger size, allowing the tabs 485 to move to theirbiased open configuration and disengaging the tabs 485 from the slots487 of the plunger 448. In this manner, the biasing member 490 will bereleased from its compressed configuration and transition towards abiased uncompressed configuration thereby resulting in travel of thepusher 437 and the pusher hub 439 distally within the handle 435. As thepusher 437 is moved distally, a distal end of the pusher 437 moves orpushes the distal coiled portion of the suture 442 (i.e., distal anchor440) over the distal end of the needle 441 and further within the leftatrium of the heart on a distal side of the mitral leaflet (see, e.g.,FIGS. 18A, 18B and 25 ), such that the coiled portion of the sutureextends distally beyond a distal end of the needle 441. For example, insome embodiments, at least half a length of the distal coiled portion ofthe suture 442 extends beyond the distal end of the needle 441. In someembodiments, at least three quarters of the length of the distal coiledportion of the suture 442 extends beyond the distal end of the needle441. In other embodiments, the entire coiled portion of the suture 442extends beyond the distal end of the needle 441. To allow the distalcoiled portion of the suture 442 (i.e., distal anchor 440) to sliderelative to the plunger 448, when the suture 442 is loaded within thedelivery device 430, there is slack SL (a portion of which is shown inFIG. 15D) in the suture 442 between the distal coiled portion of thesuture 442 and the suture lock within the suture catch 446.

After the distal coiled portion of the suture 442 is moved to the distalside of the leaflet L, the plunger 448 is released to allow the plunger448 to move proximally, which moves or pushes the needle 441 and suturecatch 446 proximally, as shown in FIG. 19A. For example, in someembodiments, the plunger 448 can be actuated by the user manuallypushing the plunger distally within the handle 435 with for example athumb or finger. To release the plunger 448, the user can release histhumb which allows the plunger 448 to be moved back proximally. Forexample, in some embodiments, when the user releases his thumb from theplunger 448, a biasing member (e.g., a spring) (not shown) can push theplunger 448 back in the proximal direction. When the suture catch 446 ismoved proximally, this in turn pulls the suture 442 (e.g., suturestrands extending from the coiled portion of the suture) proximally toform the bulky knot configuration of the distal anchor 440 against thedistal end of the pusher 437 (see e.g., FIGS. 18B, 19B, 25 and 26 ). Forexample, as described above, the bulky knot is formed by approximatingopposite ends of the coils of the elongated coil portion of the suture442 towards each other, to form one or more loops, as shown in FIG. 16B.After the distal anchor 440 has formed a knot, the proximal end portionsof the suture 442 can be released from the suture catch 446. Thedelivery device 430 can then be withdrawn proximally, leaving the distalanchor 440 disposed on the distal side of the leaflet L, as shown inFIGS. 20A and 20B, and two lengths or strands of the suture 432extending from the proximal side of the leaflet L (see e.g., FIG. 27 )and out of the heart. In other words, with the suture 442 released fromthe suture catch 446 the delivery device 430 can be slid over the suture442 for removal.

As described above for previous embodiments, the lengths or strands ofthe suture 442 between the distal anchor 440 and the opening in theheart can be adjusted until the desired length is established. Theproximal ends of the suture 442 can then be secured to an outer surfaceof the heart at, for example, the apex, with a proximal anchor (notshown). The proximal anchor can be, for example, a pledget, one or moreknots, or other suitable anchoring device. As previously described, theabove procedure can be performed multiple times on the same leaflet,and/or can be performed on the other mitral valve leaflet in the samemanner. The result can thus be that one or more anchor-tetherapparatuses (e.g., anchor-tether apparatus 145) as described above areeach anchored on a distal side of a leaflet with a distal anchor andsecured to the apex of the heart with a proximal anchor via the tether442. Alternatively, if one or more anchor-tether apparatus are attachedto both mitral valve leaflets, an anchor-tether apparatus attached toeach leaflet can be secured together in the heart by tying them togetherwith knots or by another suitable attachment member, creating anedge-to-edge repair to decrease the septal-lateral distance of themitral valve orifice. The two attached anchor-tether apparatus can beleft loose or tensioned to create a “facilitated” edge-to-edge repairbefore being secured to an outer surface of the heart with a proximalanchor. As shown in FIG. 27 , with the anchor-tether apparatus securedto the mitral valve leaflet L, when closed, the free margins or edges ofthe leaflets come together and form a tight junction, the are of whichis known as the line, plane or area of coaptation AC as previouslydescribed.

FIGS. 14A-14E described above illustrate one example method and devicefor deploying a bulky knot distal anchor using a delivery device thatutilizes a short throw deployment sequence configured to insert thedistal end portion and piercing member of the needle a shorter distanceinto the left atrium than as shown and described above for theembodiment of FIGS. 6-10 . As shown and described with respect to FIGS.14A-14E, the distal end portion of the needle is used to puncture theleaflet tissue and form an opening in the leaflet tissue, but does notextend as far into the left atrium. In another embodiment, a bulky knotdistal anchor can be deployed/formed using a delivery device thatutilizes a full forward short throw deployment sequence. The fullforward short throw deployment sequence is similar to the short throwdeployment sequence of FIGS. 14A-14E, but causes the bulky knot distalanchor to be deployed/formed by moving the pusher distally relative tothe needle rather than pulling on the proximal ends of the suture topull the coils against the distal end of the pusher. FIGS. 28A-28E areschematic illustrations of an embodiment of a delivery device fordelivering and deploying a distal anchor and configured to provide sucha full forward short throw deployment sequence.

As shown in FIGS. 28A-28E, a delivery device 530 includes a distal endportion 532, a proximal end portion 536 and a medial portion 534. Thedistal end portion 532 includes an end effector 533 that can be placedin contact with a leaflet L of a mitral valve as described above withrespect to FIGS. 14A-14E. The end effector 533 is coupled to a distalend portion of an outer tube 531 and a proximal end portion of the outertube 531 is coupled to a handle 535 at the proximal end portion 536 ofthe delivery device 530. The end effector 533 can distribute the forceof the outer tube 531 over a larger area to prevent/eliminate puncturingof the leaflet with the delivery device 530 during deployment. In someembodiments, the end effector 533 can include a balloon (not shown). Anelongate pusher 537 is movably disposed within a lumen of the outer tube531 and is coupled to a pusher hub 539 that is movably disposed withinthe handle 535 and releasably coupled to a plunger (not shown). Forexample, the plunger can be constructed the same as or similar to theplunger 448 described above and function in a similar manner. A needle541 (see FIGS. 28C-28E) is movably disposed within a lumen of the pusher537 and is coupled to a needle hub 543 that is also releasably coupledto the plunger (not shown). The plunger is used to actuate or move theneedle 541 and the pusher 537 during deployment of a distal anchor 540and can be movably disposed at least partially within the handle 535.For example, the handle 535 defines a lumen in which the plunger can bemoved. During operation, the pusher 537 also moves within the lumen ofthe handle 535 as described in more detail below. The delivery device530 can also include a locking lever (not shown) that can be used toprevent the plunger from moving within the handle 535 during storage andprior to performing a procedure to deploy the distal anchor. Forexample, the locking lever can be similar to or the same as the lockinglever 449 described above.

A suture catch 546 (also referred to as “tether catch”) can be coupledto the plunger at a proximal end of the delivery device 530. The suturecatch 546 is configured to releasably hold or secure a suture 542extending through the delivery device 530 during delivery of the distalanchor 540 as described above for previous embodiments. In someembodiments, the suture catch 546 can hold the suture 542 with afriction fit or with a clamping force and can have a lock that can bereleased after the distal anchor 540 has been deployed/formed into abulky knot.

As described above for previous embodiments, the suture 542 (alsoreferred to herein as “tether”) can be formed into an elongated coiledconfiguration and is disposed within the outer tube 531 at the distalend portion 532 of the delivery device 530. As described above, forexample, for suture 242, two strands of the suture 542 can extend fromthe distal elongated coiled portion of the suture 542, extend throughthe lumen of the needle 541, through a passageway of the plunger andexit the plunger and needle 541 at a proximal end portion of theplunger. The distal elongated coiled portion of the suture 542 will beformed into the distal anchor 540 (e.g., bulky knot) upon actuation ofthe delivery device 530 as described in more detail below. As discussedabove for previous embodiments, the distal anchor 540 can be in the formof one or more multi-turn coils of the suture 542 that can be changedfrom the elongated coiled configuration during delivery to a knotconfiguration by approximating opposite ends of the coils towards eachother, to form one or more loops.

To deliver and form the distal anchor 540 within, for example, a leftatrium of the heart to repair a mitral valve, the distal end portion of532 of the delivery device 530 can be inserted through an apex portionor region of the heart and into the left ventricle until the endeffector 533 contacts a proximal side of the mitral valve leaflet L asshown in FIG. 28A. In this embodiment, with the delivery device 530positioned against only the ventricular side of the mitral leaflet L,without contacting the atrial side of that leaflet, and with a proximalend portion of the suture 542 (e.g., two suture strands of suture 542)secured to the suture catch 546, the plunger (not shown) can be actuated(e.g., moved or pushed in a distal direction relative to the handle535). The actuation of the plunger moves the needle hub 543, the needle541, the pusher 537 and pusher hub 539, the suture catch 546, and thecoiled portion of the suture 542 (e.g., distal anchor 540) distallyuntil the needle hub 543 (and needle 541) and the suture catch 546 reacha preset location within the handle where the needle hub 543, needle541, and suture catch 546 are disengaged from the plunger and theirtravel in the distal direction is stopped. The pusher 537, the pusherhub 539, and the coiled portion of the suture 542 continue to be moveddistally by the plunger.

In some embodiments, for example, a delivery device can include arelease mechanism configured to disengage the needle hub, the needle,and the suture catch from the plunger such that the plunger can continueto advance distally and move the pusher, the pusher hub, and the coiledportion of the suture distally. In some embodiments, the releasemechanism can be configured for automatic disengagement, while in otherembodiments, the mechanism can be configured to be actuated by theoperator. In some embodiments, the delivery device can also include oneor more stop members within the handle that can engage or contact theneedle hub (and suture catch) to limit or stop the travel of the needle(and suture catch) in the distal direction.

As the plunger is actuated, and prior to the needle 541 being disengagedfrom the plunger, a distal piercing portion 547 of the needle 541, andin some cases, at least the first wrap of the coiled portion of thesuture 542, punctures the leaflet L and forms an opening in the leafletL (see e.g., FIG. 28B). The distance the distal piercing portion 547 ofthe needle 541 extends within the left atrium on the distal side of theleaflet L can be determined, for example, by the preset allowed amountof travel of the needle 541 described above (e.g., in some embodiments,the amount of travel can be determined at least in part by a stop memberwithin the handle and/or a mechanism to release the needle hub from theplunger). In some embodiments, the delivery device 530 can be configuredto advance the distal piercing portion 547 of the needle 541 a shorterdistance into the left atrium than as shown and described above for theembodiment of FIGS. 6-10 . For example, in some embodiments, the needlehub 543 can travel about 0.25 inches during actuation of the plunger. Insome embodiments, the needle 541 can be extended outside of the distalend of the delivery device (e.g., beyond the end effector) half thedistance that is shown and described for the embodiment of FIGS. 6-10 .In some embodiments, the needle 541 can be extended outside the deliverydevice a distance of about 0.2-0.3 inches (e.g., 0.25 inches).

As described above, when the needle hub 543, the needle 541 and suturecatch 546 disengage from the plunger, the plunger continues to be moveddistally, which in turn moves the pusher 537, the pusher hub 539, andthe coiled portion of the suture 542 (e.g., distal anchor 540) furtherdistally. For example, in some embodiments, the pusher 537 can be moveddistally about an additional 0.25-0.65 inches (e.g., 0.4 inches) duringactuation of the plunger. Thus, in some embodiments, the total travel ofthe pusher can be, for example, about 0.40-0.90 inches (e.g., 0.65inches). Similarly, in some embodiments, the pusher can be extendedthrough the proximal side of the heart valve leaflet a distance of about0.4-0.9 inches (e.g., 0.65 inches) from the proximal side of the heartvalve leaflet. As yet a further example of the short throw deploymentsequence, the pusher can be moved through the opening of the leafletfrom the proximal side of the leaflet and can extend a distance of about0.25-0.65 inches (e.g., 0.4 inches) from and distal to the distal sideof the leaflet.

As the pusher 537 is moved distally, with the suture catch 546, theneedle 541 and the needle hub 543 in fixed positions relative to thepusher 537 (i.e., the suture catch 546, the needle 541, and the needlehub 543 are disengaged from the plunger), a distal end of the pusher 537moves or pushes the distal coiled portion of the suture 542 (i.e.,distal anchor 540) over the distal end of the needle 541 and furtherwithin the left atrium of the heart on a distal side of the mitralleaflet (see FIG. 28C). In this manner, the distal end of the pusher 537pushes the coiled portion of the suture 542 (i.e., distal anchor 540)distally off the needle 541. To allow the distal coiled portion of thesuture 542 (i.e., distal anchor 540) to slide relative to and eventuallyoff the needle 541, when the suture 542 is loaded within the deliverydevice 530, there can be slack formed in the suture 542 between thedistal coiled portion of the suture 542 and the suture lock within thesuture catch 546. As shown in FIG. 28D, as the pusher 537 continues tomove distally relative to the needle 541, the coiled portion of thesuture 542 forms the bulky knot configuration of the distal anchor 540by approximating opposite ends of the coils of the elongated coilportion of the suture 542 towards each other, to form one or more loops(two loops are shown in FIG. 28D). For example, with the opposite endportions of the suture 542 fixed and secured within the suture catch546, as the pusher 537 moves distally, the coils are forced against thedistal end of the pusher 537 to form the knot.

In use, in some instances, the plunger can be actuated to move theneedle hub 543 as described above, while maintaining the entire distalportion of the delivery device 530 on the ventricular side of theleaflet L. In this manner, in such instances, the distal anchor 540 canbe delivered to and/or deployed at the distal side of the leafletwithout some form of mechanical fixation to and/or capturing of theleaflet L prior to piercing the leaflet with the needle 541. Unlikeconventional open-heart surgery, where the heart is stopped and thesurgeon can see and manipulate stationary leaflets, in a minimallyinvasive procedure (e.g., with a beating heart), the operator cannot seethe leaflet directly, and instead, must rely on an ultrasonic or otherimage of the moving leaflet and the device. In practice, this image isoften displayed on a display device for the operator after a slight timedelay. As such, immobilizing the otherwise moving leaflet can bechallenging and has the potential to further damage the leaflet. Beingable to deliver and deploy a distal anchor without having tomechanically fix to and/or capture the otherwise moving leaflet (e.g.,prior to piercing the leaflet to form an opening through with the distalanchor is delivered) eliminates or at least limits the challengesdiscussed above. Additionally, being able to deliver and deploy thedistal anchor using a single device (e.g., without using a separatedevice to immobilize and/or capture the leaflet) further reduceschallenges and risks associated with such procedures.

After the distal anchor 540 has formed a knot, the proximal end portionsof the suture 542 can be released from the suture catch 546 and thedelivery device 530 can be withdrawn proximally, leaving the distalanchor 540 disposed on the distal side of the leaflet L (as shown inFIG. 28E), and two lengths or strands of the suture 532 extending out ofthe heart. In other words, with the suture 542 released from the suturecatch 546 the delivery device 530 can be slid proximally over the suture542 for removal. Forming/deploying the bulky knot using the full forwardshort throw deployment sequence described above can simplify theprocedure for an operator of the delivery device 530 because theoperator can deploy the bulky knot by applying a single distal force tothe plunger. Further, after the plunger is actuated and the bulky knotis formed, the operator can remove the delivery device 530 from thepatient by withdrawing the delivery device 530 proximally without, forexample, having to wait for the plunger to move proximally to form thebulky knot, leaving the bulky knot disposed on the distal side of theleaflet L. Simplifying a procedure in this manner such that an operatorcan implant an artificial chorda by applying, for example, a push forceto the plunger, and then remove the entire delivery device bywithdrawing the delivery device proximally, promotes a repeatable andpredicable procedure.

As described above for previous embodiments, the lengths or strands ofthe suture 542 between the distal anchor 540 and the opening in theheart can be adjusted until the desired length is established. Theproximal ends of the suture 542 can then be secured to an outer surfaceof the heart at, for example, the apex region, with a proximal anchor(not shown). The proximal anchor can be, for example, a pledget, one ormore knots, or other suitable anchoring device. As previously described,the above procedure can be performed multiple times on the same leaflet,and/or can be performed on the other mitral valve leaflet in the samemanner. The result can thus be that one or more anchor-tetherapparatuses (e.g., anchor-tether apparatus 145) as described above areeach anchored on a distal side of a leaflet with a distal anchor 540 andsecured to the apex of the heart with a proximal anchor via the tether542. Alternatively, if one or more anchor-tether apparatus are attachedto both mitral valve leaflets, an anchor-tether apparatus attached toeach leaflet can be secured together in the heart by tying them togetherwith knots or by another suitable attachment member (not shown),creating an edge-to-edge repair to decrease the septal-lateral distanceof the mitral valve orifice. The two attached anchor-tether apparatuscan be left loose or tensioned to create a “facilitated” edge-to-edgerepair before being secured to an outer surface of the heart with aproximal anchor.

In some embodiments, the suture catch can be coupled in a fixed positionrelative to the handle of the delivery device, rather than being coupledto the plunger. Thus, the proximal portion of the suture coupled to thesuture catch is in a fixed position relative to the handle. In suchembodiments, there can be sufficient slack formed in the suture betweenthe distal coiled portion of the suture and the suture lock within thesuture catch to allow the distal coiled portion of the suture (i.e.,distal anchor) to slide relative to and eventually off the needle, whenthe plunger is advanced distally. Alternatively or in addition to,providing slack in the suture, a spring can be disposed in the handleand coupled to the suture between the distal coiled portion of thesuture (i.e., the distal anchor) and the suture lock, which can expandlongitudinally as the plunger is moved distally.

FIGS. 28A-28E described above illustrate one example method and devicefor deploying a bulky knot distal anchor using a delivery device thatutilizes a full forward short throw deployment sequence configured toinsert the distal end portion and piercing member of the needle ashorter distance into the left atrium than as shown and described abovefor the embodiment of FIGS. 6-10 . Such a full forward short throwdelivery sequence is configured to cause the bulky knot distal anchor tobe deployed/formed by moving the pusher distally relative to the needlerather than pulling on the proximal ends of the suture to pull the coilsagainst the distal end of the pusher. In another embodiment, a bulkyknot distal anchor can be deployed/formed using a delivery device thatutilizes an independent full forward short throw deployment sequence.The independent full forward short throw deployment sequence is similarto the full forward short throw deployment sequence of FIGS. 28A-28E,except the pusher and the needle are configured to move independent ofeach other (e.g., the pusher and the needle can each be coupled to adifferent component of the actuator and/or be actuated separately). Forexample, the pusher and needle can be moved within the handle and theouter tube independently of each other and during varying time periodsin response to separate force-providing mechanisms. FIGS. 29A-29E areschematic illustrations of an embodiment of a delivery device fordelivering and deploying a distal anchor using an independent fullforward short throw deployment sequence.

As shown in FIGS. 29A-29E, a delivery device 630 includes a distal endportion 632, a proximal end portion 636 and a medial portion 634. Thedistal end portion 632 includes an end effector 633 that can be placedin contact with a leaflet L of a mitral valve as described above withrespect to previous embodiments. The end effector 633 is coupled to adistal end portion of an outer tube 631 and a proximal end portion ofthe outer tube 631 is coupled to a handle 635 at the proximal endportion 636 of the delivery device 630. The end effector 633 candistribute the force of the outer tube 631 over a larger area toprevent/eliminate puncturing of the leaflet with the delivery device 630during deployment. In some embodiments, the end effector 633 can includea balloon (not shown). An elongate pusher 637 is movably disposed withina lumen of the outer tube 631 and is coupled to a pusher hub 639 that ismovably disposed within the handle 635 and coupled to an actuator (notshown). The actuator can be used to actuate or move the pusher hub 639and the pusher 637 during deployment of a distal anchor 640 and can bemovably disposed at least partially within the handle. A needle 641 (seeFIG. 29B) is movably disposed within a lumen of the pusher 637 and iscoupled to a needle hub 643 that is coupled to an actuator (not shown)and/or energy storage member (not shown). The actuator can be used toactuate or move the needle hub 643 and the needle 641 (both independentof the pusher hub and the pusher) during deployment of the distal anchor640 and can be movably disposed at least partially within the handle635. For example, the handle 635 can define a lumen in which theactuator or a portion of the actuator can be actuated and/or moved. Thedelivery device 630 can also include a locking lever (not shown) thatcan be used to prevent the actuator(s) and/or one or more of itsconstituent components from actuating and/or moving within or relativeto the handle 635 during, for example, storage and/or prior toperforming a procedure to deploy the distal anchor. For example, thelocking lever can be similar to or the same as the locking lever 449described above.

A suture catch 646 (also referred to as “tether catch”) can be coupledto a proximal end of the delivery device 630. The suture catch 646 isconfigured to releasably hold or secure a suture 642 extending throughthe delivery device 630 during delivery of the distal anchor 640 asdescribed above for previous embodiments. In some embodiments, thesuture catch 646 can hold the suture 642 with a friction fit or with aclamping force and can have a lock that can be released after the distalanchor 640 has been deployed/formed into a bulky knot.

As described above for previous embodiments, the suture 642 (alsoreferred to herein as “tether”) can be formed into an elongated coiledconfiguration and is disposed within the outer tube 631 at the distalend portion 632 of the delivery device 630. As described above, forexample, for suture 242, two strands of the suture 642 can extend fromthe distal elongated coiled portion of the suture 642, and extendthrough the lumen of the needle 641. The distal elongated coiled portionof the suture 642 will be formed into the distal anchor 640 (e.g., bulkyknot) upon actuation of the delivery device 630 as described in moredetail below. As discussed above for previous embodiments, the distalanchor 640 can be in the form of one or more multi-turn coils of thesuture 642 that can be changed from the elongated coiled configurationduring delivery to a knot configuration by approximating opposite endsof the coils towards each other, to form one or more loops.

To deliver and form the distal anchor 640 within, for example, a leftatrium of the heart to repair a mitral valve, the distal end portion of632 of the delivery device 630 can be inserted through an apex portionof the heart and into the left ventricle until the end effector 633contacts a proximal side of the mitral valve leaflet L as shown in FIG.29A. In this embodiment, with the delivery device 630 positioned againstonly the ventricular side of the mitral leaflet L, and with a proximalend portion of the suture 642 (e.g., two suture strands of suture 642)secured to the suture catch 646, the actuator can be actuated and/ormoved to move both the needle hub 643 and the needle 641 distallyrelative to the handle 635, the pusher hub 639 and the pusher 637. Theneedle hub 643 and the needle 641 (with the coiled portion of the suture642 coupled thereto) are moved distally until the needle hub 643 andneedle 641 reach a preset location within the handle 635, at which pointtheir travel in the distal direction is stopped.

In some embodiments, the delivery device can also include one or morestop members within the handle that can engage or contact the needle hubto limit or stop the travel of the needle in the distal direction.

As the needle 641 is advanced distally within the handle 635, a distalpiercing portion (not shown) of the needle 641, and in some cases, atleast the first wrap of the coiled portion of the suture 642, puncturesthe leaflet L and forms an opening in the leaflet L (see e.g., FIG.29B). The distance the distal piercing portion of the needle 641 extendswithin the left atrium on the distal side of the leaflet L can bedetermined, for example, by the preset allowed amount of travel of theneedle 641 described above (e.g., in some embodiments, the amount oftravel can be determined at least in part by a stop member within thehandle and/or a mechanism disposed within the handle 635. In someembodiments, the delivery device 630 can be configured to advance thedistal piercing portion of the needle 641 a shorter distance into theleft atrium than as shown and described above for the embodiment ofFIGS. 6-10 . For example, in some embodiments, the needle hub 643 cantravel about 0.25 inches. In some embodiments, the needle can beextended outside of the distal end of the delivery device (e.g., beyondthe end effector) half the distance that is shown and described for theembodiment of FIGS. 6-10 . In some embodiments, the needle can beextended outside the delivery device a distance of about 0.2-0.3 inches(e.g., 0.25 inches).

With a portion of the needle 641 disposed within the left atrium, anactuator (not shown) (e.g. a plunger or other type of actuatormechanism) can be actuated and/or moved to cause the pusher hub 639 andin turn the pusher 637 to move distally within the handle 635 andrelative to the needle 641 and needle hub 643, as shown by FIG. 29C. Inthis manner, the pusher 637 can urge the coiled portion of the suture642 (e.g., the distal anchor 640) further distally relative to theneedle 641, as described in further detail herein. For example, in someembodiments, with the end effector 633 in contact with the proximal sideof the mitral valve leaflet L, the pusher 637 can be moved distallyabout 0.65 inches.

As the pusher 637 is moved distally, with the suture catch 646, theneedle 641 and the needle hub 643 in fixed positions relative to thepusher 637, a distal end of the pusher 637 moves or pushes the distalcoiled portion of the suture 642 (i.e., distal anchor 640) over thedistal end of the needle 641 and further within the left atrium of theheart on a distal side of the mitral leaflet (see FIG. 29C). In thismanner, the distal end of the pusher 637 pushes the coiled portion ofthe suture 642 (i.e., distal anchor 640) distally off the needle 641. Toallow the distal coiled portion of the suture 642 (i.e., distal anchor640) to slide relative to and eventually off the needle 641, when thesuture 642 is loaded within the delivery device 630, there can be slackformed in the suture 642 between the distal coiled portion of the suture642 and the suture lock within the suture catch 646. As shown in FIG.29D, as the pusher 637 continues to move distally relative to the needle641, the coiled portion of the suture 642 forms the bulky knotconfiguration of the distal anchor 640 by approximating opposite ends ofthe coils of the elongated coil portion of the suture 642 towards eachother, to form one or more loops (two loops are shown in FIG. 29D). Forexample, with the opposite end portions of the suture 642 fixed andsecured within the suture catch 646, as the pusher 637 moves distally,the coils are forced against the distal end of the pusher 637 to formthe knot.

After the distal anchor 640 has formed a knot, the proximal end portionsof the suture 642 can be released from the suture catch 646 and thedelivery device 630 can be withdrawn proximally, leaving the distalanchor 640 disposed on the distal side of the leaflet L (as shown inFIG. 29E), and two lengths or strands of the suture 632 extending out ofthe heart. In other words, with the suture 642 released from the suturecatch 646, the delivery device 630 can be slid proximally over thesuture 642 for removal. In some embodiments, after the distal anchor 640has formed a knot, and the proximal end portions of the suture 642 arereleased from the suture catch 646, the needle 641 and/or the pusher 637can be withdrawn proximally within and relative to the outer tube 631.In some instances, the needle 641 and/or the pusher 637 are withdrawnproximally into the outer tube 631 before the delivery device 630 iswithdrawn proximally, while in other instances, the needle 641 and/orthe pusher 637 are withdrawn proximally into the outer tube 631 as thedelivery device 630 is withdrawn proximally.

As described above for previous embodiments, the lengths or strands ofthe suture 642 between the distal anchor 640 and the opening in theheart can be adjusted until the desired length is established. Theproximal ends of the suture 642 can then be secured to an outer surfaceof the heart at, for example, the apex region, with a proximal anchor(not shown). The proximal anchor can be, for example, a pledget, one ormore knots, or other suitable anchoring device. As previously described,the above procedure can be performed multiple times on the same leaflet,and/or can be performed on the other mitral valve leaflet in the samemanner. Thus, as a result, one or more anchor-tether apparatuses (e.g.,anchor-tether apparatus 145) can be anchored on a distal side of aleaflet with a distal anchor 640 and secured to the apex of the heartwith a proximal anchor via the tether 642. Alternatively, if one or moreanchor-tether apparatus are attached to both mitral valve leaflets, ananchor-tether apparatus attached to each leaflet can be secured togetherin the heart by tying them together with knots or by another suitableattachment member (not shown), creating an edge-to-edge repair todecrease the septal-lateral distance of the mitral valve orifice. Thetwo attached anchor-tether apparatus can be left loose or tensioned tocreate a “facilitated” edge-to-edge repair before being secured to anouter surface of the heart with a proximal anchor.

In some embodiments, alternatively or in addition to providing slack inthe suture, a spring can be disposed in the handle and coupled to thesuture between the distal coiled portion of the suture (i.e., the distalanchor) and the suture lock, which can expand longitudinally as thedistal anchor is moved distally relative to the handle as describedabove.

In another embodiment, a bulky knot distal anchor can be deployed/formedusing a delivery device that utilizes an independent short throwdeployment sequence. The independent short throw deployment sequence issimilar to the independent full forward short throw deployment sequenceof FIGS. 29A-29E, except the bulky knot distal anchor is deployed/formedby pulling on the proximal ends of the suture to pull the coils againstthe distal end of the pusher rather than moving the pusher distallyrelative to the needle. Similar to the embodiment of FIGS. 29A-29E, forexample, the pusher and needle can be moved within the outer tubeindependently of each other and during varying time periods in responseto separate force-providing mechanisms and/or separate energy storagemembers. Further, similar to the embodiment of FIGS. 14A-14E, the needlecan be moved proximally within and relative to the handle, pulling thesuture (e.g., suture strands extending from the coiled portion of thesuture) proximally through the pusher to form the bulky knotconfiguration of the distal anchor. FIGS. 30A-30E are schematicillustrations of an embodiment of a delivery device for delivering anddeploying a distal anchor and configured to provide such an independentshort throw deployment sequence.

As shown in FIGS. 30A-30E, a delivery device 730 includes a distal endportion 732, a proximal end portion 736 and a medial portion 734. Thedistal end portion 732 includes an end effector 733 that can be placedin contact with a leaflet L of a mitral valve as described above withrespect to previous embodiments. The end effector 733 is coupled to adistal end portion of an outer tube 731 and a proximal end portion ofthe outer tube 731 is coupled to a handle 735 at the proximal endportion 736 of the delivery device 730. The end effector 733 candistribute the force of the outer tube 731 over a larger area toprevent/eliminate puncturing of the leaflet with the delivery device 730during deployment. In some embodiments, the end effector 733 can includea balloon (not shown). An elongate pusher 737 is movably disposed withina lumen of the outer tube 731 and is coupled to a pusher hub 739 that ismovably disposed within the handle 735 and coupled to an actuator (notshown) and/or energy storage member (not shown). The actuator and/orenergy storage member can be used to actuate or move the pusher hub 739and the pusher 737 during deployment of a distal anchor 740 and can bemovably disposed at least partially within the handle. A needle 741 (seeFIG. 30B) is movably disposed within a lumen of the pusher 737 and iscoupled to a needle hub 743 that is coupled to an actuator (not shown).The actuator can be used to actuate or move the needle hub 743 and theneedle 741 (both independent of the pusher hub and the pusher) duringdeployment of the distal anchor 740 and can be movably disposed at leastpartially within the handle 735. For example, the handle 735 defines alumen in which the actuator or a portion of the actuator can be actuatedand/or moved. The delivery device 730 can also include a locking lever(not shown) that can be used to prevent the actuator and/or one or moreof its constituent components from actuating and/or moving within orrelative to the handle 735 during storage and prior to performing aprocedure or a particular portion thereof to deploy the distal anchor.For example, the locking lever can be similar to or the same as thelocking lever 449 described above.

A suture catch 746 (also referred to as “tether catch”) can be coupledto a proximal end of the delivery device 730. The suture catch 746 isconfigured to releasably hold or secure a suture 742 extending throughthe delivery device 730 during delivery of the distal anchor 740 asdescribed above for previous embodiments. In some embodiments, thesuture catch 746 can hold the suture 742 with a friction fit or with aclamping force and can have a lock that can be released after the distalanchor 740 has been deployed/formed into a bulky knot.

As described above for previous embodiments, the suture 742 (alsoreferred to herein as “tether”) can be formed into an elongated coiledconfiguration and is disposed within the outer tube 731 at the distalend portion 732 of the delivery device 730. As described above, forexample, for suture 242, two strands of the suture 742 can extend fromthe distal elongated coiled portion of the suture 742, and extendthrough the lumen of the needle 741. The distal elongated coiled portionof the suture 742 will be formed into the distal anchor 740 (e.g., bulkyknot) upon actuation of the delivery device 730 as described in moredetail below. As discussed above for previous embodiments, the distalanchor 740 can be in the form of one or more multi-turn coils of thesuture 742 that can be changed from the elongated coiled configurationduring delivery to a knot configuration by approximating opposite endsof the coils towards each other, to form one or more loops.

To deliver and form the distal anchor 740 within, for example, a leftatrium of the heart to repair a mitral valve, the distal end portion of732 of the delivery device 730 can be inserted through an apex portionof the heart and into the left ventricle until the end effector 733contacts a proximal side of the mitral valve leaflet L as shown in FIG.30A. In this embodiment, with the delivery device 730 positioned againstonly the ventricular side of the mitral leaflet L, and with a proximalend portion of the suture 742 (e.g., two suture strands of suture 742)secured to the suture catch 746, the actuator and/or energy storagemember can be actuated and/or moved to move both the needle hub 743 andthe needle 741 distally relative to the handle 735, the pusher hub 739and the pusher 737. The needle hub 743 and the needle 741 (with thecoiled portion of the suture 742 coupled thereto) are moved distallyuntil the needle hub 743 and needle 741 reach a preset location withinthe handle 735, at which point their travel in the distal direction isstopped.

In some embodiments, the delivery device can also include one or morestop members within the handle that can engage or contact the needle hubto limit or stop the travel of the needle in the distal direction.

As the needle 741 is advanced distally within the handle 735, a distalpiercing portion (not shown) of the needle 741, and in some cases, atleast the first wrap of the coiled portion of the suture 742, puncturesthe leaflet L and forms an opening in the leaflet L (see e.g., FIG.30B). The distance the distal piercing portion of the needle 741 extendswithin the left atrium on the distal side of the leaflet L can bedetermined, for example, by the preset allowed amount of travel of theneedle 741 described above (e.g., in some embodiments, the amount oftravel can be determined at least in part by a stop member within thehandle and/or a mechanism disposed within the handle 735). In someembodiments, the delivery device 730 can be configured to advance thedistal piercing portion of the needle 741 a shorter distance into theleft atrium than as shown and described above for the embodiment ofFIGS. 6-10 . For example, in some embodiments, the needle hub 743 cantravel about 0.25 inches. In some embodiments, the needle can beextended outside of the distal end of the delivery device (e.g., beyondthe end effector) half the distance that is shown and described for theembodiment of FIGS. 6-10 . In some embodiments, the needle can beextended outside the delivery device a distance of about 0.2-0.3 inches(e.g., 0.25 inches).

With a portion of the needle 741 disposed within the left atrium, anactuator (not shown) can be actuated and/or moved to cause the pusherhub 739 and in turn the pusher 737 to move distally within the handle735 and relative to the needle 741 and needle hub 743, as shown by FIG.30C. In this manner, the distal end portion of the pusher 737 can urge,push, or otherwise move the coiled portion of the suture 742 (e.g., thedistal anchor 740) off and distal to the needle 741, as described infurther detail herein. For example, in some embodiments, with the endeffector 733 in contact with the proximal side of the mitral valveleaflet L, and the needle 741 in a fixed position relative to the pusher737, the pusher 737 can be moved distally about 0.65 inches.

As the pusher 737 is moved distally, and with the suture catch 746, theneedle 741 and the needle hub 743 in fixed positions relative to thepusher 737, a distal end of the pusher 737 moves or pushes the distalcoiled portion of the suture 742 (i.e., distal anchor 740) over thedistal end of the needle 741 and further within the left atrium of theheart on a distal side of the mitral leaflet (see FIG. 30C). In otherwords, the distal end of the pusher 737 and the distal coiled portion ofthe suture 742 extend beyond the distal end of the needle 741. Forexample, in some embodiments, at least half a length of the distalcoiled portion of the suture 742 extends beyond the distal end of theneedle 741. In some embodiments, at least three quarters of the lengthof the distal coiled portion of the suture 742 extends beyond the distalend of the needle 741. In other embodiments, the entire length of thedistal coiled portion of the suture 742 extends beyond the distal end ofthe needle 741. To allow the distal coiled portion of the suture 742(i.e., distal anchor 740) to slide relative to and eventually off theneedle 741, when the suture 742 is loaded within the delivery device730, there can be slack formed in the suture 742 between the distalcoiled portion of the suture 742 and the suture lock within the suturecatch 746.

After the distal coiled portion of the suture 742 is moved to the distalside of the leaflet L, the needle hub 743 and the needle 741 are movedproximally relative to the pusher 737, pulling the suture 742 (e.g.,suture strands extending from the coiled portion of the suture 742)through the pusher 737 to form the bulky knot configuration (as shown inFIG. 30D) of the distal anchor 740 by approximating opposite ends of thecoils of the elongated coil portion of the suture 742 towards eachother, to form one or more loops. As shown in FIG. 30D, by pulling onthe proximal ends of the suture 742, the coils are pulled against thedistal end of the pusher 737 to form the knot. After the distal anchor740 has formed a knot, the proximal end portions of the suture 742 canbe released from the suture catch 746 and the delivery device 730 can bewithdrawn proximally, leaving the distal anchor 740 disposed on thedistal side of the leaflet L (as shown in FIG. 30E), and two lengths orstrands of the suture 732 extending out of the heart. In other words,with the suture 742 released from the suture catch 746, the deliverydevice 730 can be slid over the suture 742 for removal.

In some embodiments, after the distal anchor 740 has formed a knot, andthe proximal end portions of the suture 742 are released from the suturecatch 746, the needle 741 and/or the pusher 737 can be withdrawnproximally within and relative to the outer tube 731. In some instances,the needle 741 and/or the pusher 737 are withdrawn proximally into theouter tube 731 before the delivery device 730 is withdrawn proximally,while in other instances, the needle 741 and/or the pusher 737 arewithdrawn proximally into the outer tube 731 as the delivery device 730is withdrawn proximally.

As described above for previous embodiments, the lengths or strands ofthe suture 742 between the distal anchor 740 and the opening in theheart can be adjusted until the desired length is established. Theproximal ends of the suture 742 can then be secured to an outer surfaceof the heart at, for example, the apex region, with a proximal anchor(not shown). The proximal anchor can be, for example, a pledget, one ormore knots, or other suitable anchoring device. As previously described,the above procedure can be performed multiple times on the same leaflet,and/or can be performed on the other mitral valve leaflet in the samemanner. As a result, one or more anchor-tether apparatuses (e.g.,anchor-tether apparatus 145) as described above are each anchored on adistal side of a leaflet with a distal anchor 740 and secured to theapex of the heart with a proximal anchor via the tether 742.Alternatively, if one or more anchor-tether apparatus are attached toboth mitral valve leaflets, an anchor-tether apparatus attached to eachleaflet can be secured together in the heart by tying them together withknots or by another suitable attachment member (not shown), creating anedge-to-edge repair to decrease the septal-lateral distance of themitral valve orifice. The two attached anchor-tether apparatus can beleft loose or tensioned to create a “facilitated” edge-to-edge repairbefore being secured to an outer surface of the heart with a proximalanchor.

In some embodiments, alternatively or in addition to providing slack inthe suture, a spring can be disposed in the handle and coupled to thesuture between the distal coiled portion of the suture (i.e., the distalanchor) and the suture lock, which can expand longitudinally as thedistal anchor is moved distally relative to the handle as describedabove.

FIG. 31 shows a schematic illustration of a distal anchor 840 shown inan elongated coiled configuration. The distal anchor 840 can bedelivered and deployed within a heart using any of the delivery devicesdescribed herein. For ease of explanation, the distal anchor 840 isshown and described with reference to a first section 860 of the suture842 and a second section 870 of the suture 842. The first section 860has a first portion 861 (as shown in dashed line for ease ofillustration) and a second portion 862 including a first coil 863 formedof multiple turns about the exterior of the distal end portion 832 ofthe delivery device 830. The first coil 863 has a proximal end 864 and adistal end 865. The second portion 862 of the first section 860 has afirst end 866 at the distal end 865 of the first coil 863.

The second section 870 has a second portion 872 with a first end 876,and extends proximally from the first end 866 of the first section 860through an interior of the first coil 863 (and through the lumen of thedistal end portion 832 of the deliver device 830) to the proximal end864 of the first coil 863. The second section 870 also includes a loopforming segment 877 that extends distally from a first end 878 of theloop forming segment 877 at the proximal end 864 of the first coil 863along the outside of the first coil 863 to the distal end 865 of thefirst coil 863, and extends proximally through the interior of the firstcoil 863 (and through the lumen of the distal end portion 832 of thedeliver device 830) to the proximal end 864 of the first coil 863 at asecond end 879 of the loop forming segment 877.

The second portion 872 of the second section 870 includes a second coil873 formed of multiple turns about the exterior of the distal endportion 832 of the delivery device 830 proximal to the first coil 863,and has a proximal end 874 and a distal end 875. The second portion 872of the second section 870 extends proximally from the first end 876 ofthe second portion 872 through the interior of the second coil 873 (andas shown in FIGS. 32A-32E, e.g., through the lumen of the distal endportion 832 of the deliver device 830) to the proximal end 874 of thesecond coil 873. The first end 878 of the loop forming segment 877 ofthe second portion 872 of the second section 870 extends from the distalend 875 of the second coil 873.

The second portion 862 of the first section 860 has a loop formingsegment 867 that extends from a first end 868 of the loop formingsegment 867 of the second portion 862 of the first section 860proximally from the proximal end 864 of the first coil 863 along theoutside of the second coil 873 to the proximal end 874 of the secondcoil 873 and extends distally through the interior of the second coil873 (and as shown in FIGS. 32A-32E, e.g., through the lumen of thedistal end portion 832 of the deliver device 830) to the distal end 875of the second coil 873 at a second end 869 of the loop forming segment867 of the second portion 862 of the first section 860. The firstportion 861 of the first section 860 extends proximally from the secondend 869 of the loop forming segment 867 of the second portion 862 of thefirst section 860.

FIGS. 32A-32E illustrate in sequence the formation of the distal anchor840 of FIG. 31 about an exterior of a needle 841 of a delivery device(not shown) and in an elongated coiled configuration (FIG. 32E). Theneedle 841 defines a lumen L therethrough and a slot (not shown) incommunication with the lumen L. To form the distal anchor 840 about theneedle 841, the second portion 872 of the second section 870 of thesuture 842 is routed through the lumen L of the needle 841 (see e.g.,FIG. 32A). Next, the second portion 862 of the first section 860 of thesuture 842 is wrapped about the needle 841 to form the first coil 863(see e.g., FIG. 32B). Similarly, the second portion 872 of the secondsection 870 of the suture 842 is wrapped about the needle 841 proximateto the first coil 863 to form the second coil 873 (see e.g., FIG. 32C).

After formation of the first coil 863 and the second coil 873 about theneedle 841, the loop forming segment 867 of the second portion 862 ofthe first section 860 is formed by routing proximally the sectionportion 862 of the first section 860 of the suture 842 from the proximalend 864 of and exterior to the first coil 863 towards the proximal end874 of the second coil 873 (see e.g., FIG. 32C), and then extendingdistally through the interior of the second coil (see e.g., FIG. 32D).In a similar manner, the loop forming segment 877 of the second portion872 of the second section 870 is formed by routing distally the secondportion 872 of the second section 870 of the suture 842 from the distalend 875 of the second coil 873 towards the distal end 865 of the firstcoil 863 (see e.g., FIG. 32C), and then extending proximally through theinterior of the first coil 863 to the proximal end 864 of the first coil863 (see e.g., FIG. 32D). The first portion 861 of the first section 860of the suture 842 and the first portion 871 (as shown in dashed line forease of illustration) of the second section 870 of the suture 842extends from the lumen L of the needle 841 through the slot (not shown)of the needle 841 to an area external to the needle 841 such that eachportion 861, 871 can be manipulated (e.g., pulled proximally) to formthe knot, as described above.

FIGS. 33A-33D illustrate an example method of preparing a deliverydevice 930 to deliver a distal anchor 940 (e.g., and to form a bulkyknot distal anchor) to be disposed on a distal side of a mitral valveleaflet. The delivery device 930 can be constructed the same as orsimilar to, and function the same as or similar to, for example, thedelivery device 430 or any other delivery device described herein. Itshould be understood that for features and functions not specificallydiscussed with respect to the delivery device 930, those features andfunctions can be the same as or similar to the delivery device 430 orany of the delivery devices described herein.

The guide member 955 is configured to be coupled to the proximal end ofa pusher hub 939 as illustrated by arrow A in FIG. 33A and disposedwithin a lumen defined by the biasing member 990 shown in FIG. 30B. Asillustrated in FIG. 33B, the biasing member 990 is configured to be slidover the needle 941 that is coupled to a needle hub (not shown) disposedwithin a plunger 948.

To couple the pusher hub 939 to the plunger 948, the pusher hub 939 isslid over the needle 941 towards the distal end of the plunger 948, asshown by arrow B in FIG. 33C, until the guide member 955 and the biasingmember 990 are inserted into a lumen defined by the plunger 948 and thetabs 985 of the pusher hub 939 are aligned with corresponding slots (notshown) defined by the plunger 948. As the pusher hub 939 is slid towardsand eventually coupled to the plunger 948, the biasing member 990 iscompressed or otherwise loaded with potential energy. Although not shownin FIGS. 33A-33D, the delivery device 930 can include a handle, andsimilar to as described herein with respect to the tabs 485 and thehandle 435 of FIGS. 17A and 18A, when the pusher hub 939 is coupled tothe plunger 948 (as shown by FIG. 33D), the tabs are compressed by theinner walls of the handle. As illustrated in detailed view by FIG. 33E,the needle 941 is movably disposed within the lumen defined by thepusher 937.

FIGS. 34A-34H illustrate an example method of forming the distal anchor940 in an elongated coiled configuration (FIG. 34H) about an exterior ofthe needle 941. The distal anchor 940 (formed of a suture 942) and theneedle 941 can be constructed similar to or the same as and functionsimilar to or the same as any of the distal anchors and needlesdescribed herein with respect to previous embodiments. The needle 941defines an interior lumen L, and a distal portion of the needle 941includes a slot SL in communication with the lumen. As shown in FIG.34A, the second portion 972 of the second section 970 of the suture 942is routed through the slot SL of the needle 941 and between the knotrings 980. The knot rings 980 (e.g., silicon O-rings) are disposed aboutthe suture 942 and the needle 941 to secure the suture 942 to and withinthe slot SL of the needle 941. In this manner, the knot rings 980 definethe outer edges (or the distal end 965 of the first coil 963 and theproximal end 974 of the second coil 973) of the distal anchor 940, andcan secure the suture 942 such that the first coil 963 and the secondcoil 973 can be formed about the needle 941.

To form the first coil 963 and the second coil 973, the needle 941 isrotated such that the free ends (or the second portion 962 of the firstsection 960 and the second portion 972 of the second section 970) of thesuture 942 form multiple turns about the exterior of the needle 941, asshown in FIG. 34B. Next, the loop forming segment 967 of the secondportion 962 of the first section 960 is formed by routing proximally thesecond portion 962 of the first section 960 of the suture 942 from theproximal end 964 of and exterior to the first coil 963 towards theproximal end 974 of the second coil 973, and then extending distallythrough the interior of the second coil 973 to the distal end 975 of thesecond coil 973, as shown in FIG. 34C. In a similar manner, the loopforming segment 977 of the second portion 972 of the second section 970is formed by routing distally the second portion 972 of the secondsection 970 of the suture 942 from the distal end 975 of the second coil973 towards the distal end 965 of the first coil 963, and then extendingproximally through the interior of the first coil 963 to the proximalend 964 of the first coil 963, as shown in FIG. 34D.

To further prepare the distal anchor 940 for delivery to a heart, asdescribed in previous embodiments, the loop forming segments can beshortened and/or tightened by pulling the first portion 961 of the firstsection 960 of the suture 942 and the first portion 971 of the secondsection 970 of the suture 942. Such a configuration is shown in FIG.34E. Once the loop forming segments 967, 977 are formed, the knot rings980 can be removed from the needle 932 and the suture 942. Upon removalof the knot rings 980, the loop forming segments 967, 977 can be furthershortened or tightened, as shown in FIGS. 34F and 34G. Next, the firstportion 961 of the first section 960 of the suture 942 and the firstportion 971 of the second section 970 of the suture 942 can be routedproximally into a distal end of the interior lumen L of the needle 941and proximally through the interior lumen L, as shown in FIGS. 34G and34H.

In some embodiments, a snare 993 can be used to facilitate routing ofthe suture 942 and forming of the distal anchor 942, as illustrated inFIGS. 34C, 34D, and 34 G. For example, the snare 993 can be used toroute the first portion 961 of the first section 960 and the firstportion 971 of the second section 970 into the interior lumen L of theneedle and proximally through the interior lumen L.

In another embodiment of a distal anchor, the circumferential windingsof the knot in the knot distal anchor 940 described above are replacedby a single flexible tube. Such an embodiment of a distal anchor isillustrated in FIGS. 35 and 36 . FIG. 35 illustrates a distal anchor1040 in an elongated delivery configuration, and FIG. 36 illustrates thedistal anchor 1040 in a deployed configuration. In this embodiment, theflexible tube 1044 has a distal portion 1045, and a proximal portion1056, and a slit 1046 separating the distal portion 1045 from theproximal portion 1056. In an alternative embodiment, instead of a singleflexible tube 1044, the anchor 1040 can be formed with a separate distaltube and proximal tube (not shown), separated by a gap, rather than apartial circumference slit in a middle portion of a single flexibletube, as shown in FIG. 35 . The suture 1043 is routed into and throughthe slit 1046, into a lumen of the flexible tube 1044, extendingdistally through the lumen from the slit 1045 towards and through adistal end 1065 of the distal portion 1045, then extending proximallyalong the exterior of the flexible tube 1044 towards and through aproximal end 1074 of the proximal portion 1056, then extending distallyinto and through the lumen of the flexible tube 1044 towards and throughthe distal end 1065 of the distal portion 1045, then extendingproximally along the exterior of the flexible tube 1044 towards andthrough the proximal end 1074 of the proximal portion 1056, and thenextending distally through the lumen of the flexible tube 1044 towardsand through the slit 1045 and outside of the flexible tube 1044, asshown in FIG. 35 .

Similar to the knot distal anchors described above with respect toprevious embodiments, the distal anchor 1040 can be deployed in asimilar manner using the delivery devices described above with respectto those embodiments. For example, the distal anchor 1040 can bedelivered in the elongate configuration (FIG. 35 ) and moved to thedeployed configuration (FIG. 36 ) by pulling the suture strands 1042proximally to deflect the distal end 1065 of the distal portion 1045 ofthe flexible tube 1044 laterally with respect to a proximal end 1064 ofthe distal portion 1045 of the flexible tube 1044 to draw the proximalend 1064 and the distal end 1065 of the distal portion 1045 of theflexible tube 1044 towards each other to form a loop L as shown in FIG.36 . Similarly, the suture strands 1042 can be pulled proximally todeflect the distal end 1075 of the proximal portion 1056 of the flexibletube 1044 laterally with respect to a proximal end 1074 of the proximalportion 1056 of the flexible tube 1044 to draw the proximal end 1074 andthe distal end 1075 of the proximal portion 1056 of the flexible tube1044 towards each other to form a loop L as shown in FIG. 33 .

In another embodiment of a distal anchor, the circumferential windingsof the knot in the knot distal anchor 240 described above are replacedby a T-fastener, as shown in an elongated delivery configuration in FIG.37 . Similar to the knot distal anchor 240 described above, the distalanchor (or T-fastener) 1140 can be deployed in a similar manner usingany of the delivery devices described above with respect to previousembodiments. For example, the distal anchor 1140 can be coupled to asuture or sutures 1142 and removably coupled to or otherwise in operablecontact with a pusher 1134. The distal anchor 1140 can be delivered inthe elongate configuration and moved to the deployed configuration bypulling the suture 1142 proximally to rotate the distal anchor 1140 suchthat the distal anchor 1140 is non-parallel with respect to the pusher1134, the distal end portion of the delivery device 1130, and/or thesuture 1142. Simultaneously, the distal anchor 1140 can be decoupled orotherwise separated from (not shown) the pusher 1134 as the pusher 1134is moved distally relative to a handle (not shown) of the deliverydevice and the suture 1142 is pulled proximally.

In another embodiment of a distal anchor, the circumferential windingsof the knot in the knot distal anchor 240 described above are replacedby an expandable distal anchor, as shown in FIGS. 38A-38D. FIG. 38Aillustrates the distal anchor 1240 in an elongated deliveryconfiguration disposed within a lumen defined by and disposed throughthe distal end portion 1232 of the delivery device. FIG. 38B illustratesthe distal anchor 1240 in the elongated deliver configuration anddisposed outside of and distal to the distal end portion 1232 of thedelivery device. FIGS. 38C and 38D illustrate the distal anchor 1240 ina deployed configuration in side and perspective view, respectively.Similar to the knot distal anchor 240 described above, the distal anchor1240 can be deployed in a similar manner using any of the deliverydevices described above with respect to previous embodiments. Forexample, the distal anchor 1240 can be coupled to a suture 1242 (ordisposed about the suture 1242 such that the suture 1242 extends througha lumen defined by the distal anchor 1240) having a stopper 1290disposed at a distal end of the suture 1242. The suture 1242 isremovably coupled to or otherwise in operable contact with a pusher1234. The distal anchor 1240 can be delivered in the elongateconfiguration (see e.g., FIGS. 38A and 38B) and moved to the deployedconfiguration by pulling the suture 1242 proximally and/or moving thepusher 1234 distally as shown in FIGS. 38C and 38D. In this manner, boththe stopper 1290 and the pusher 1234 can collectively facilitate thetransition of the distal anchor 1240 from the elongated deliveryconfiguration to the radially expanded deployed configuration.

In another embodiment of a distal anchor, the expandable distal anchor1240 described above is replaced by a double expandable distal anchor,as shown in FIGS. 39A-39C. FIG. 39A illustrates the distal anchor 1340in an elongated delivery configuration. FIG. 39B illustrates the distalanchor 1340 in a partially deployed configuration. FIG. 39C illustratesthe distal anchor 1340 in a deployed configuration. Similar toexpandable distal anchor 1240 described above, the distal anchor 1340can be deployed in a similar manner using, for example, any of thedelivery devices described above with respect to previous embodiments.For example, the distal anchor 1340 can be disposed about a suture 1342such that the suture 1342 extends through a lumen defined by the distalanchor 1340, and removably coupled to or otherwise in operable contactwith a pusher (not shown). The distal anchor 1340 can be delivered inthe elongate configuration (see e.g., FIG. 39A) and moved to thedeployed configuration (see e.g., FIGS. 39B and 39C) by pulling thesuture 1342 proximally and/or moving the pusher (not shown) distally. Inthis embodiment, the distal anchor 1340 includes two slits. As thesuture 1342 is pulled proximally and/or the pusher (not shown) is moveddistally, the slits facilitate expansion of two portions of the distalanchor 1340, as shown in FIG. 39B. In its deployed configuration, theends of the first slit and the ends of the second slit are brought intoor nearly into contact with one another, as shown in FIG. 39C tomaximize the expansion of the two portions of the distal anchor 1340.

In use, in some embodiments, the distal anchor 1340 is delivered in theelongate configuration (see e.g., FIG. 39A) through an opening in aleaflet (e.g., a prolapsed segment of a native mitral valve leaflet)until a medial portion 1341 of the distal anchor 1340 is disposed in theopening of the leaflet and a first slit is disposed in the left atriumof the heart and the second slit is disposed in the left ventricle ofthe heart. The distal anchor 640 is then moved into its deployedconfiguration (see e.g., FIGS. 39B and 39C) such that the two portions(defined in part by the slits) expand radially and/or laterally. In thismanner, the two portions of the distal anchor 1340 can collectivelygrab, grasp, sandwich, or otherwise maintain a portion of the nativevalve leaflet therebetween. In addition to operably coupling the distalanchor 1340 to the native valve leaflet, the distal anchor 1340 whendeployed provides a seal across the opening of the leaflet to prevent orotherwise limit any fluid flow through the opening. In some embodiments,the portions of the distal anchor 1340 can be deployed (e.g., expanded)simultaneously, while in other embodiments the portions of the distalanchor 1340 can be deployed sequentially, e.g., the distal portion canbe deployed at a first time and the proximal portion can be deployed ata second time after the first time, or vice versa.

In another embodiment of a distal anchor, the circumferential windingsof the knot in the knot distal anchor 240 described above are replacedby an expandable distal anchor (or umbrella anchor), as shown in FIGS.40A-37C. FIG. 40A illustrates the distal anchor 1440 in an elongatedcollapsed delivery configuration and proximate to a distal end portion1432 of a delivery device. FIG. 40B illustrates the distal anchor 1440in a partially deployed configuration. FIG. 40C illustrates the distalanchor 1440 in a deployed or expanded configuration and disposed distalto a valve leaflet VL. In this embodiment, during delivery of the distalanchor 1440, the interior walls of the distal end portion 1432 canretain the distal anchor 1440 in its elongated delivery configurationwhen the distal anchor 1440 is disposed within a lumen defined by thedistal end portion 1432. When in the elongated delivery configuration,an open end portion 1440 a of the distal anchor 1440 is disposedproximal to a rounded distal end 1440 b of the distal anchor as shown inFIG. 40A. Similar to distal anchor 240 described above, the distalanchor 1440 can be deployed in a similar manner using any of thedelivery devices described above with respect to previous embodiments.For example, the distal anchor 1440 can be coupled to a suture 1442 andremovably coupled to or otherwise in operable contact with a pusher1434. The distal anchor 1440 can be delivered in the elongateconfiguration (see e.g., FIG. 40A), and moved to the deployedconfiguration (see e.g., FIGS. 40B and 40C) by pulling the suture 1442proximally and/or moving the pusher 1434 distally. As the distal anchor1440 is moved distally and the open end portion 1440 a exits the distalend portion 1432 of the delivery device, the distal anchor 1440 isallowed to expand (i.e., the open end 1440 a opens) towards its deployedor expanded configuration, as shown in FIG. 40B.

In an alternative embodiment, a distal anchor can be configured similarto the distal anchor 1440 except that the distal anchor can be disposedon the suture 1442 such that the open end of the umbrella shaped portionis distal to the rounded distal end of the distal anchor. In such anembodiment, the rounded distal end can define a hole through which thesuture can be extended and secured. The distal anchor can be formed withfor example a shape-memory material such that the distal anchor has abiased expanded or deployed configuration and an elongated collapsedconfiguration when constrained within a delivery device. The distalanchor can be pushed or moved out of a delivery device with, forexample, a pusher device. As the distal anchor exits a distal end of thedelivery device, the distal anchor can transition from its elongatedcollapsed configuration to its expanded, deployed or biasedconfiguration. Said another way, as the distal anchor exits the distalend of the delivery device, the open end of the distal anchor opens toits expanded or biased configuration. In this manner, the distal anchorcan transition from its delivery configuration to its deployedconfiguration as it exits the delivery device.

In another embodiment of a distal anchor, the circumferential windingsof the knot in the knot distal anchor 240 described above are replacedby an expandable distal anchor, as shown in FIGS. 41A-41D. In thisembodiment, the distal anchor 1540 includes elongate members 1540 b withfree ends 1540 a and a stopper receiving section 1591. FIG. 41Aillustrates the distal anchor 1540 in an elongated deliveryconfiguration and disposed within a lumen defined by a distal endportion 1532 of a delivery device such that the free ends 1540 a ofelongate members 1540 b are disposed proximal to the stopper receivingsection 1591 of the distal anchor 1540. FIG. 41B illustrates the distalanchor 1540 in the elongated delivery configuration. FIGS. 41C and 41Dillustrate the distal anchor 1540 in a deployed configuration. In thisembodiment, a distal end portion of the suture 1542 includes a stopper1590 and the stopper receiving section 1591 of the distal anchor 1540 isconfigured to cooperatively mate with the stopper 1590. During deliveryof the distal anchor 1540, the interior walls of the distal end portion1532 can retain the distal anchor 1540 in its elongated deliveryconfiguration when the distal anchor 1540 is disposed within a lumendefined by the distal end portion 1532, as shown in FIG. 38A. Similar todistal anchor 240 described above, the distal anchor 1540 can bedeployed in a similar manner using any of the delivery devices describedabove with respect to previous embodiments. For example, the distalanchor 1540 can be coupled to a suture 1542 and removably coupled to orotherwise in operable contact with a pusher 1534. The distal anchor 1540can be delivered in the elongated configuration (see e.g., FIG. 41A) andmoved to the deployed configuration (see e.g., FIGS. 41B and 41C) bypulling the suture 1542 proximally and/or moving the pusher 1534distally (see e.g., FIG. 41C). In this manner, the stopper 1590 of thesuture 1542 can be moved into contact with the stopper receiving section1591, and the stopper 1590 and the stopper receiving section 1591 cancollectively facilitate the transition of the distal anchor 1540 fromthe elongated delivery configuration to the expanded deployedconfiguration.

In an alternative embodiment, a distal anchor can be configured similarto the distal anchor 1540 except that the distal anchor can be disposedon the suture 1542 such that the free ends of the elongate members aredistal to the stopper receiving section. In such an embodiment, thedistal anchor can be formed with for example a shape-memory materialsuch that the distal anchor has a biased expanded or deployedconfiguration and an elongated collapsed configuration when constrainedwithin a delivery device. The distal anchor can be pushed or moved outof a delivery device with, for example, a pusher device. As the distalanchor exits the delivery device, a distal end of the distal anchor cantransition from its elongated collapsed configuration to its expanded,deployed or biased configuration. Said another way, as the distal anchorexits the distal end of the delivery device, the free ends of theelongate members can extend radially towards the deployed or biasedconfiguration of the distal anchor. In this manner, the distal anchorcan transition from its delivery configuration to its deployedconfiguration as it exits the delivery device.

The distal anchor 1540 can be formed of any suitable material, such as,for example a malleable stainless steel, a shape memory or superelasticalloy, or a polymer. One such polymer, for example, can includepolyaryletherketones (PAEKs) such as polyetheretherketone (PEEK).Optionally, in some embodiments, a distal anchor can include or becoupled to a material (e.g., a fabric and/or polymer) that is configuredto distribute an anchor load, cover and/or seal the hole made in theleaflet, and/or promote ingrowth or an otherwise desirable biologicalresponse when the distal anchor is disposed within a heart. For example,as illustrated in FIGS. 42A and 42B, the distal anchor 1540 of FIGS.41A-41D can have such a material 1592 coupled thereto. For example, insome embodiments, the material 1592 can extend between the elongatemembers 1540 b and beyond the free ends 1540 a of the distal anchor1540, as shown in FIG. 42A. In some embodiments, the material 1592 canbe sized and shaped to replicate or nearly replicate the size and shapeof the elongate members 1540 b of the distal anchor 1540, as shown inFIG. 42B.

In another embodiment of a distal anchor, the circumferential windingsof the knot in the knot distal anchor 240 described above are replacedby an expandable distal anchor, as shown in FIGS. 43A-43C. FIG. 43Aillustrates a distal end portion of the distal anchor 1640 in a deployedconfiguration. FIG. 43B illustrates a proximal end portion of the distalanchor 1640 in the deployed configuration. FIG. 43C illustrates inpartial cross-section the distal anchor 1640 in the deployedconfiguration. In this embodiment, a distal end portion of the suture1642 includes a stopper 1690. A radial support member 1694 is coupledand disposed proximal to the proximal end portion of the distal anchor1640. The radial support member 1694 can prevent or otherwise limit thedistal anchor 1640 from undesirably flipping or deflecting (1) beyond aplane defined by the stopper 1690, and/or (2) distal to the stopper1690. The radial support member 1694 can be made of any suitablematerial sufficient to provide radial support, such as, for example, anon-elastic material. In addition, as shown best in FIG. 43C, the distalanchor 1640 is pre-configured to have a slight angle.

Similar to distal anchor 240 described above, the distal anchor 1640 canbe deployed in a similar manner using any of the delivery devicesdescribed above with respect to previous embodiments. For example, thedistal anchor 1640 can be coupled to the suture 1642 and removablycoupled to or otherwise in operable contact with a pusher (not shown).The distal anchor 1640 can be delivered in the elongated configuration(not shown) and moved to the deployed configuration by pulling thesuture 1642 proximally and/or moving the pusher (not shown) distally, asshown in FIGS. 43A-43C. In this manner, the stopper 1690 of the suture1642 can be moved into contact with the distal end portion of the distalanchor 940, and as a result, can collectively facilitate the transitionof the distal anchor 1640 from the elongated delivery configuration (notshown) to the expanded deployed configuration. Although not shown, insome embodiments, the distal anchor 1640 can include radial stiffeningmembers in addition to or instead being coupled to the radial supportmember 1694.

In another embodiment of a distal anchor, the circumferential windingsof the knot in the knot distal anchor 240 described above are replacedby an expandable braid, as shown in FIGS. 44A-44E. FIG. 44A illustratesthe expandable braid distal anchor 1740 in an elongated deliveryconfiguration, FIG. 44B illustrates the distal anchor 1740 in theelongated delivery configuration with reference to a valve leaflet L,and FIG. 44C illustrates the distal anchor 1740 in cross-section in theelongated delivery configuration. FIG. 44D illustrates the distal anchor1740 in an expanded or deployed configuration with reference to a valveleaflet L, and FIG. 44E illustrates in cross-section the distal anchor1740 in the deployed configuration. In this embodiment, the expandablebraid distal anchor 1740 has a distal portion 1745, a proximal portion1756, and a distal collar 1795 disposed therebetween. The distal anchor1740 also includes a proximal collar 1796 disposed proximal to theproximal portion 1756 of the distal anchor 1740. Similar to the knotdistal anchor 240 described above, the distal anchor 1740 can bedeployed in a similar manner using any of the delivery devices describedabove with respect to previous embodiments. For example, the distalanchor 1740 can be coupled to a suture 1742. The distal anchor 1740 canbe delivered in the elongate configuration and moved to the deployedconfiguration by pulling the suture strands 1742 proximally to cause thebraided distal portion 1745 and the braided proximal portion 1756 toexpand radially, as shown in FIGS. 44D and 44E.

Prior to deployment of the expandable braid distal anchor 1740, thedistal collar 1795 can be aligned with and disposed at least partiallywithin the hole formed in the leaflet L, as shown in FIG. 44B. In thismanner, when deployed (radially expanded), the distal portion 1745 ofthe distal anchor 1740 will be disposed on the distal side of theleaflet L (e.g., within the atrium of the heart), and the proximalportion 1746 of the distal anchor 1740 will be disposed on the proximalside of the leaflet L (e.g., within the ventricle of the heart), asshown in FIG. 44D. Deployment of the distal portion 1745 and theproximal portion 1746 can be initiated in stages. For example,deployment of the distal portion 1745 can be initiated while theproximal portion 1746 is in the elongated delivery configuration, anddeployment of the proximal portion 1746 can be initiated after thedistal portion 1745 has transitioned into the deployed configuration.

Further to this example, in use, the distal anchor 1740 can be insertedinto the atrium of the heart and the distal portion 1745 can be deployedwithin the atrium. Next, the suture 1742 can be pulled proximally suchthat a proximal side surface of the distal portion 1745 of the distalanchor 1740 is brought into contact with an atrial side of the heartvalve leaflet L. In this manner, the distal portion 1745 can bemanipulated into a desirable position before the proximal portion 1746of the distal anchor 1740 is deployed. Once the distal portion 1745 issuitable positioned against the valve leaflet L, the proximal portion1746 of the distal anchor 1740 can be deployed such that a distal sidesurface of the proximal portion 1746 is brought into contact with aventricle side of the valve leaflet L, thereby securing the leaflet Lbetween the distal portion 1745 and the proximal portion 1746.

Although not shown, in some embodiments, the distal anchor 1740 caninclude a locking mechanism configured to lock, bias, or otherwisemaintain the distal anchor 1740 in its expanded deployed configuration.Further, in some embodiments, the distal portion 1745 and the proximalportion 1746 can be formed of shape memory or superelastic material suchthat its expanded deployed configuration is its unbiased configuration.

In another embodiment of a distal anchor, the circumferential windingsof the knot in the knot distal anchor 240 described above are replacedby a single flexible tube, as shown in FIGS. 45A-45C. FIG. 45Aillustrates the distal anchor 1840 in an elongated deliveryconfiguration, and FIGS. 45B and 45C illustrate the distal anchor 1840in a deployed configuration, in side view and perspective view,respectively. In this embodiment, the flexible tube 1840 has a distalportion 1845, and a proximal portion 1856, and a medial portion 1846disposed therebetween. Each portion is separated by a hinge section,i.e., a first hinge section 1897 is disposed between the distal portion1845 and the medial portion 1846, and a second hinge section 1898 isdisposed between the medial portion 1846 and the proximal portion 1856.The suture 1842 includes a stopper 1890 at its distal end, and extendstherefrom through a first aperture AP1, a second aperture AP2 and athird aperture AP3, each of which is defined by the flexible tube 1840,as shown in FIGS. 45A-45C.

Similar to the knot distal anchor 240 described above, the distal anchor1840 can be deployed in a similar manner using any of the deliverydevices described above with respect to previous embodiments. The distalanchor 1840 can be delivered in the elongate configuration and moved tothe deployed configuration by pulling the suture strand 1842 proximallyto deflect the portions 1845, 1846, 1156 about their respective hingesections 1897, 1898, as shown in FIGS. 45B and 45C. In this manner, theportions 1845, 1846, 1856 are drawn towards each other (or folded ontoone another) to form the expanded deployed configuration.

The distal anchor 1840 can be formed of any suitable material, e.g.,ePFTE or a similar biocompatible polymer. In an alternative embodiment,instead of a single flexible tube 1844, the anchor 1840 can be formed ofseparate portions and then coupled together. Further, in an alternativeembodiment, instead of three portions (i.e., distal, proximal, medial),the anchor 1840 can include any suitable number of portions (e.g., asingle portion or four or more portions).

In another embodiment of a distal anchor, the circumferential windingsof the knot in the knot distal anchor 240 described above are replacedby a hinged tube, as shown in FIGS. 46A and 43B. FIG. 46A illustratesthe distal anchor 1940 in an elongated delivery configuration, and FIG.46B illustrates schematically the distal anchor 1940 in a deployedconfiguration. In this embodiment, the hinged tube 1940 has a distalportion 1945, and a proximal portion 1956, and hinge sections HS tofacilitate deployment, deflection or bending of the distal portion 1945and the proximal portion 1956 at desirable sections of the distal anchor1940. A distal end portion of an elongated tube 1999 is fixedly coupledto a distal end of the distal portion 1945 of the distal anchor 1940,and extends through a lumen defined by the distal anchor 1940, out aproximal end of the proximal portion 1945 of the distal anchor 1940, andthen coupled to a suture 1942, as shown in FIG. 46A. Similar to the knotdistal anchor 240 described above, the distal anchor 1940 can bedeployed in a similar manner using any of the delivery devices describedabove with respect to previous embodiments. For example, the distalanchor 1940 can be delivered in the elongate configuration and moved tothe deployed configuration by pulling the suture strand 1942 proximally,and thereby similarly moving the elongated tube 1999 proximally with thesuture strand 1942, to deflect the hinged tube 1940 laterally withrespect to the hinge sections HS to form the deployed or expandedconfiguration, as shown in FIG. 46B.

While some of the distal anchors described above as being delivered to aleft ventricle of a heart, piercing a native mitral valve leaflet fromthe ventricular side to the atrial side, deploying the distal anchor onthe atrial side of the leaflet, and anchoring the distal anchor to anapex region of the heart, in other instances, the distal anchorsdescribed above can be delivered and deployed via other suitablemethods, e.g., transfemorally, transatrially and/or via an inferior venacava (IVC). For example, in some embodiments, one or more native valveleaflets can be pierced from the atrial side to the ventricular side,and the distal anchor can be delivered from the atrial side to theventricular side and deployed in the ventricle. In such embodiments, insome instances, the distal anchor can be attached or otherwise coupledto (e.g., via a suture) a second distal anchor (e.g., deployed at asecond leaflet). In some instances, the distal anchor can be anchored tothe apical region of the heart by routing a suture attached to theanchor through the area or void between the leaflets from the atrialside to the ventricular side.

It should be understood that the distal anchors described herein can bedelivered and deployed using any of the delivery devices describedherein or any other suitable delivery device. While some embodimentsdescribed herein have included delivery devices configured to deploy abulky knot distal anchor, in other embodiments, those delivery devicescan be configured to deliver and deploy any suitable distal anchor, suchas, for example, any of the distal anchors illustrated in FIGS. 35-46B.

It should be understood that although in various embodiments describedherein the puncture member was shown and described as defining aninternal lumen through which an artificial chorda can extend, in otherembodiments, any of the delivery devices described herein can include apuncture member having a solid shaft along which an artificial chordacan extend. In such embodiments, for example, a proximal end portion ofthe artificial chorda can be coupled to an actuator of the deliverydevice.

Although in various embodiments described herein, such as, for example,the embodiments described with reference to full forward deploymentsequences, a portion of the suture is illustrated and described as beingcoupled to the actuator and/or a suture catch, in alternativeembodiments, a portion (e.g., a proximal end portion) of the suture canbe coupled (e.g., fixedly coupled) to any suitable portion of thedelivery device. For example, in some embodiments, a proximal endportion of the suture can be fixedly coupled to the handle of thedelivery device.

In various embodiments described herein, to allow the distal anchor toslide relative to the actuator, when the suture is loaded within thedelivery device, there is slack in the suture between the distal anchorand the suture lock within the suture catch (or other location at whichthe proximal end portion of the suture is fixedly coupled). Inalternative embodiments, in addition to or instead of the slack, anysuitable mechanism can be used. For example, in some embodiments, aspring or the like can be coupled to the suture and a portion of thehandle of the delivery device such that the distal anchor can slide asdiscussed in further detail herein.

It should be understood that although in various embodiments describedherein the delivery device includes an outer tube and an end effector,in other embodiments, a delivery device can be constructed similar toand can function similar to any of the delivery devices describedherein, except the delivery device does not include an outer tube and anend effector. In such embodiments, for example, in some instances, thedelivery device can deliver and deploy a distal anchor in cooperationwith a separate device or devices configured to function similar to orthe same as the outer tube and/or end effectors described herein. Forexample, in some instances, an introducer valve, sheath, catheter or thelike can be used. In such instances, the puncture member and/or pusherdevice can be movably disposed within the introducer valve as thepuncture member and/or pusher device are used to delivery and deploy thedistal anchor. In some embodiments, an end effector can be disposed at adistal end portion of the introducer valve.

While various embodiments of delivery devices have been described abovewith respect to procedures conducted by a human operator (e.g., asurgeon), in some embodiments, the delivery device can be configured tooperate in conjunction with robotics used in, for example, roboticassisted surgery. Similarly stated, a robotic assisted procedure can beperformed using the delivery devices described above.

While various embodiments have been described above with respect to atrans-apical approach and via a left atrium of a heart, in someembodiments, an anchor-tether apparatus can be delivered transfemorally(e.g., using a catheter). In some instances, for example, native mitralvalve leaflets can be pierced from an atrial side to a ventricular sideof the leaflets, and the free ends of the sutures can be securedtogether (e.g., an edge-to-edge repair). In other instances, as anotherexample, after piercing a native mitral valve leaflet from the atrialside to the ventricular side of the leaflet, the free end of the suturecan extend beyond the free edge of the leaflet towards the ventricle andbe secured to the ventricular wall or through the apex of the heart andsecured outside of the heart, as described with respect to previousembodiments. As a further example, in some instances, the anchor-tetherapparatus can be delivered transfemorally, and the delivery device canpierce the native mitral valve leaflet from the ventricular side to theatrial side, and the sutures can be secured together or routed into theventricle and secured to the ventricle wall.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Where methods described above indicate certain eventsoccurring in certain order, the ordering of certain events may bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above.

Where schematics and/or embodiments described above indicate certaincomponents arranged in certain orientations or positions, thearrangement of components may be modified. While the embodiments havebeen particularly shown and described, it will be understood thatvarious changes in form and details may be made. Any portion of theapparatus and/or methods described herein may be combined in anycombination, except mutually exclusive combinations. The embodimentsdescribed herein can include various combinations and/orsub-combinations of the functions, components and/or features of thedifferent embodiments described.

Depending on the embodiment, certain acts, events, or functions of anyof the processes described herein can be performed in a differentsequence, may be added, merged, or left out altogether. Thus, in certainembodiments, not all described acts or events are necessary for thepractice of the processes. Moreover, in certain embodiments, acts orevents may be performed concurrently.

Conditional language used herein, such as, among others, “can,” “could,”“might,” “may,” “e.g.,” and the like, unless specifically statedotherwise, or otherwise understood within the context as used, isintended in its ordinary sense and is generally intended to convey thatcertain embodiments include, while other embodiments do not include,certain features, elements and/or steps. Thus, such conditional languageis not generally intended to imply that features, elements and/or stepsare in any way required for one or more embodiments or that one or moreembodiments necessarily include logic for deciding, with or withoutauthor input or prompting, whether these features, elements and/or stepsare included or are to be performed in any particular embodiment. Theterms “comprising,” “including,” “having,” and the like are synonymous,are used in their ordinary sense, and are used inclusively, in anopen-ended fashion, and do not exclude additional elements, features,acts, operations, and so forth. Also, the term “or” is used in itsinclusive sense (and not in its exclusive sense) so that when used, forexample, to connect a list of elements, the term “or” means one, some,or all of the elements in the list. Conjunctive language such as thephrase “at least one of X, Y and Z,” unless specifically statedotherwise, is understood with the context as used in general to conveythat an item, term, element, etc. may be either X, Y or Z. Thus, suchconjunctive language is not generally intended to imply that certainembodiments require at least one of X, at least one of Y and at leastone of Z to each be present.

It should be appreciated that in the above description of embodiments,various features are sometimes grouped together in a single embodiment,figure, or description thereof for the purpose of streamlining thedisclosure and aiding in the understanding of one or more of the variousinventive aspects. This method of disclosure, however, is not to beinterpreted as reflecting an intention that any claim require morefeatures than are expressly recited in that claim. Moreover, anycomponents, features, or steps illustrated and/or described in aparticular embodiment herein can be applied to or used with any otherembodiment(s). Further, no component, feature, step, or group ofcomponents, features, or steps are necessary or indispensable for eachembodiment. Thus, it is intended that the scope of the inventions hereindisclosed and claimed below should not be limited by the particularembodiments described above, but should be determined only by a fairreading of the claims that follow.

What is claimed is:
 1. A tissue anchor delivery device comprising: ahandle; an elongate shaft extending from the handle; a pusher tubedisposed at least partially within a lumen of the elongate shaft; apusher hub coupled to the pusher tube; a needle disposed at leastpartially within a lumen of the pusher tube; a needle hub coupled to theneedle; and an actuator configured to be fixed to the pusher hub and theneedle hub, the actuator further being configured to: advance the needlehub and the pusher hub a first distance, thereby causing a tip of theneedle to protrude from a distal end of the elongate shaft; disengagefrom the needle hub; and advance the pusher hub a second distancerelative to the needle hub, thereby causing a distal end of the pushertube to advance over the needle and push a coiled suture form off of theneedle.
 2. The tissue anchor delivery device of claim 1, wherein theactuator is further configured to be travel a third distance to causethe coiled suture form to convert to a knot form.
 3. The tissue anchordelivery device of claim 2, wherein said converting the coiled sutureform to the knot form comprises approximating two or more ends of thecoiled suture form to form one or more loops.
 4. The tissue anchordelivery device of claim 2, wherein said travelling the third distanceby the actuator causes the pusher hub to advance the third distance topush the coiled suture form to cause the coiled suture form to convertto the knot form.
 5. The tissue anchor delivery device of claim 2,wherein said travelling the third distance by the actuator is in aproximal direction and causes one or more suture tails associated withthe coiled suture form to be pulled proximally.
 6. The tissue anchordelivery device of claim 1, further comprising: the coiled suture formwrapped around a distal portion of the needle; and a suture catchconfigured to hold one or more suture tails associated with the coiledsuture form.
 7. The tissue anchor delivery device of claim 6, wherein aportion of the one or more suture tails between the coiled suture formand the suture catch has slack therein to allow for advancement of thecoiled suture form relative to the suture catch.
 8. The tissue anchordelivery device of claim 1, wherein said disengaging of the actuatorfrom the needle hub is caused by contact with a stopper within thehandle.
 9. The tissue anchor delivery device of claim 1, wherein thehandle includes a stop member that, when contacted by at least one ofthe actuator, the needle hub, or the pusher hub, causes at least one ofthe pusher hub or the needle hub to release from the actuator.
 10. Thetissue anchor delivery device of claim 1, wherein the actuator comprisesa plunger configured to be manually pushed by a user.
 11. The tissueanchor delivery device of claim 1, wherein the first distance is set byat least one of a stop member or a hub-release mechanism of the handle.12. The tissue anchor delivery device of claim 1, wherein: the firstdistance is between 0.2-0.3 inches; and the second distance is between0.25-0.65 inches.
 13. The tissue anchor delivery device of claim 1,wherein the handle is configured to limit an amount of travel of theneedle hub to the first distance to limit a protrusion distance of thetip of the needle.
 14. The tissue anchor delivery device of claim 1,wherein, when the needle hub has travelled the first distance, theneedle hub is automatically locked in-place relative to the handle. 15.A tissue anchor delivery device comprising: a handle; an elongate shaft;a needle disposed at least partially within the elongate shaft; a coiledsuture form wound around a distal portion of the needle; a pusherdisposed at least partially within the elongate shaft; a needle hubfixed to the needle and configured to advance within the handle a firstpreset distance to project a tip of the needle from a distal end of theelongate shaft; and a pusher hub fixed to the pusher and configured toadvance within the handle a second preset distance to pass a distal endof the pusher beyond the tip of the needle a sufficient distance to pushthe coiled suture form off of the needle and push a proximal portion ofthe coiled suture form distally towards a distal portion of the coiledsuture form to form one or more loops of a knot.
 16. The tissue anchordelivery device of claim 15, further comprising a suture catchconfigured to hold one or more suture tails associated with the coiledsuture form.
 17. The tissue anchor delivery device of claim 16, whereina portion of the one or more suture tails between the coiled suture formand the suture catch has slack therein to allow for advancement of thecoiled suture form relative to the suture catch.
 18. The tissue anchordelivery device of claim 15, wherein the needle hub is configured to bereleasably coupled with an actuator carriage that is actuatable by auser.
 19. The tissue anchor delivery device of claim 15, wherein thehandle includes a stop member that, when contacted by at least one ofthe needle hub, the pusher hub, or an actuator coupled to at least oneof the needle hub or the pusher hub, causes the needle hub to decouplefrom the actuator.
 20. The tissue anchor delivery device of claim 15,wherein the needle hub and the pusher hub are controllable throughmanual engagement with a plunger actuator of the tissue anchor deliverydevice.